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Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years (AIM)

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ClinicalTrials.gov Identifier: NCT00489268
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : June 30, 2011
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Medtronic - MITG

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Barrett Esophagus
Intervention Device: HALO Ablation System
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Hide Arm/Group Description The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
Period Title: Overall Study
Started 1 10 10 11 70
Completed 1 10 9 11 50
Not Completed 0 0 1 0 20
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II Total
Hide Arm/Group Description The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2 Total of all reporting groups
Overall Number of Baseline Participants 1 10 10 11 70 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 10 participants 10 participants 11 participants 70 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
 100.0%
10
 100.0%
8
  80.0%
7
  63.6%
54
  77.1%
80
  78.4%
>=65 years
0
   0.0%
0
   0.0%
2
  20.0%
4
  36.4%
16
  22.9%
22
  21.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 10 participants 10 participants 11 participants 70 participants 102 participants
Female
0
   0.0%
0
   0.0%
2
  20.0%
1
   9.1%
18
  25.7%
21
  20.6%
Male
1
 100.0%
10
 100.0%
8
  80.0%
10
  90.9%
52
  74.3%
81
  79.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 10 participants 10 participants 11 participants 70 participants 102 participants
United States 1 10 10 11 52 84
Puerto Rico 0 0 0 0 18 18
1.Primary Outcome
Title Percentage of Participants With Histological Clearance of Barrett's Metaplasia
Hide Description The primary study outcomes were defined as the percent of patients with complete histological response to intestinal metaplasia (IM) (CR-IM). CR-IM means complete eradication of IM (diseased epithelium). A patient was considered a Complete Responder (CR) if all biopsies (100%) were negative for intestinal metaplasia (CR-IM).
Time Frame 5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done per protocol.
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Hide Arm/Group Description:
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
Overall Number of Participants Analyzed 1 10 10 11 70
Measure Type: Number
Unit of Measure: Percent of Participants
100 20 78 82 92
2.Secondary Outcome
Title Progression of Histological Grade
Hide Description Secondary outcomes of progression of histological grade was defined as proportion of participants who had progression of disease such as (i) prevalence of dysplasia; (ii) Kaplan-Meier CR-IM (Complete Response to Intestinal Metaplasia) survival analysis.
Time Frame 5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done per protocol.
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Hide Arm/Group Description:
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
Overall Number of Participants Analyzed 1 10 10 11 70
Measure Type: Number
Unit of Measure: Percent of Participants
0 0 0 0 0
3.Secondary Outcome
Title Adverse Events
Hide Description The secondary outcome adverse events was defined as any event that occurred during the course of the trial
Time Frame 5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done per protocol.
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Hide Arm/Group Description:
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
Overall Number of Participants Analyzed 1 10 10 11 70
Measure Type: Number
Unit of Measure: Participants
0 0 7 0 28
4.Secondary Outcome
Title Percentage of Participants With Sub-squamous Intestinal Metaplasia
Hide Description The secondary outcome sub-squamous intestinal metaplasia was defined as prevalence of buried glandular mucosa in the esophagus.
Time Frame 5 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was done per protocol.
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Hide Arm/Group Description:
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
Overall Number of Participants Analyzed 1 10 10 11 70
Measure Type: Number
Unit of Measure: Percent of Participants
0 0 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Hide Arm/Group Description The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study. The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
All-Cause Mortality
Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/11 (0.00%)   0/70 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: 6 J/cm^2 Phase I: 8 J/cm^2 Phase I: 10 J/cm^2 Phase I: 12 J/cm^2 Phase II
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/10 (0.00%)   0/10 (0.00%)   0/11 (0.00%)   0/70 (0.00%) 
Study had no concurrent control arm, biopsy forceps were not standardized for all cases, the original patient group comprised 70 patients, whereas 69 and 61 patients were available at 1 and 2.5 years, respectively, 60 eligible patients at 5 years.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: David E. Fleischer, M.D.
Organization: Mayo Clinic, Arizona
Phone: (480) 301-4461
Responsible Party: David S. Utley, MD, BÂRRX Medical, Inc.
ClinicalTrials.gov Identifier: NCT00489268     History of Changes
Other Study ID Numbers: B-200
First Submitted: June 19, 2007
First Posted: June 21, 2007
Results First Submitted: March 7, 2011
Results First Posted: June 30, 2011
Last Update Posted: March 13, 2017