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Trial record 44 of 223 for:    "Barrett syndrome"

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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Phase I: 6 J/cm^2 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.
Phase I: 8 J/cm^2 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.
Phase I: 10 J/cm^2 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.
Phase I: 12 J/cm^2 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.
Phase II 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

Participant Flow:   Overall Study
    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
STARTED   1   10   10   11   70 
COMPLETED   1   10   9   11   50 
NOT COMPLETED   0   0   1   0   20 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Phase I: 6 J/cm^2 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.
Phase I: 8 J/cm^2 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.
Phase I: 10 J/cm^2 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.
Phase I: 12 J/cm^2 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.
Phase II 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 1   10   10   11   70   102 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of 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 
[Units: Participants]
           
United States   1   10   10   11   52   84 
Puerto Rico   0   0   0   0   18   18 


  Outcome Measures

1.  Primary:   Percentage of Participants With Histological Clearance of Barrett's Metaplasia   [ Time Frame: 5 year ]

2.  Secondary:   Progression of Histological Grade   [ Time Frame: 5 year ]

3.  Secondary:   Adverse Events   [ Time Frame: 5 year ]

4.  Secondary:   Percentage of Participants With Sub-squamous Intestinal Metaplasia   [ Time Frame: 5 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: fleischer.david@mayo.edu


Publications of Results:

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