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Trial record 18 of 227 for:    "Barrett syndrome"

HALO Patient Registry: Ablation of Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT00848237
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : February 5, 2016
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Barrett Esophagus
Intervention Device: Radiofrequency Ablation (HALO Ablation Systems)
Enrollment 5521

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment
Hide Arm/Group Description

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Period Title: Overall Study
Started 5521
Completed 4982
Not Completed 539
Arm/Group Title Treatment
Hide Arm/Group Description

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Baseline Participants 5521
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5521 participants
<=18 years 1
Between 18 and 65 years 3235
>=65 years 2279
[1]
Measure Description: Note: 6 subjects: Age unknown
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5521 participants
61.6  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5521 participants
Female
1469
  26.6%
Male
4052
  73.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5521 participants
5521
1.Primary Outcome
Title Endoscopic Clearance Rate for Barrett's Esophagus-Percentage of Patients With no Endoscopically Visible Barrett's Esophagus at 1 Year Follow-up
Hide Description % of patients with 100 % resolution at 1 year follow-up. This endpoint is a visual and not reliable or accurate. A better measure of clearance of Barrett's esophagus is based on biopsies.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
4011 subjects provided the answers
Arm/Group Title Treatment
Hide Arm/Group Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Participants Analyzed 4011
Measure Type: Number
Unit of Measure: percentage of participants
62.1
2.Primary Outcome
Title Histological Clearance Rate for Intestinal Metaplasia (CE-IM)
Hide Description Percentage of patients with no histological evidence of intestinal metaplasia at 1 year follow-up
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
4118 provided biopsies at least 1 year post RFA
Arm/Group Title Treatment
Hide Arm/Group Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Participants Analyzed 4118
Measure Type: Number
Unit of Measure: percentage of participants
85.5
3.Primary Outcome
Title Histological Clearance Rate for Dysplasia (CE-D)
Hide Description percentage of patients with baseline dysplasia who have no histological evidence of dysplasia at 1 year follow-up
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
4118 provided biopsies at least 1 year post RFA and non dysplasia subjects from 4118 were removed for CE-D analysis
Arm/Group Title Treatment
Hide Arm/Group Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Participants Analyzed 2224
Measure Type: Number
Unit of Measure: percentage of participants
93.5
4.Primary Outcome
Title Percentage of Patients With Sub-squamous Intestinal Metaplasia at 1 Year Follow up
Hide Description Percentage of patients at 1 year follow-up with sub-squamous intestinal metaplasia, with or without dysplasia, that is covered completely by an intact layer of squamous epithelium with no communication with the surface
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Participants Analyzed 5521
Measure Type: Number
Unit of Measure: percentage of patients with SSIM
2.7
5.Primary Outcome
Title Patient Quality of Life Questionnaire Results: Change From Baseline to 12 Month
Hide Description Patient who completed both baseline and follow-up Quality of Life: Scores (0-10) of quality of life at baseline and 12 month follow-up were measured and changes were calculated ( 12 months minus baseline) in: concerns about the condition of esophagus, negative impact on life and esophageal cancer worry. Scale range is 0-10, 0 is min and 10 is max. Higher value represent worse outcome (such as higher concern about the condition of esophagus, negative impact on life and higher esophageal cancer worry).
Time Frame 12 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
943 subjects completed both baseline and follow up quality of life life survey
Arm/Group Title Treatment
Hide Arm/Group Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Participants Analyzed 943
Mean (Standard Deviation)
Unit of Measure: units on a scale
Changes:concern about the condition of esophagus -2.7  (3.2)
Negative impact on life -1.9  (3.0)
Esophageal cancer worry -2.8  (3.4)
6.Primary Outcome
Title Adverse Event Incidence
Hide Description Adverse and Serious Adverse event with Definite device relationship
Time Frame 12 month
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment
Hide Arm/Group Description:

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

Overall Number of Participants Analyzed 5521
Measure Type: Number
Unit of Measure: participants
66
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.

Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy.

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   24/5521 (0.43%) 
Injury, poisoning and procedural complications   
Pain, Nausea, vomitting, fullness, abdominal discomfort *  6/5521 (0.11%) 
Dysphagia and/or Odynophagia *  2/5521 (0.04%) 
aspiration *  1/5521 (0.02%) 
Dysphagia/Upper GI Bleed *  1/5521 (0.02%) 
Esophageal spasms *  1/5521 (0.02%) 
Esophagitis and/or Ulceration *  2/5521 (0.04%) 
Fever *  2/5521 (0.04%) 
Hematemesis *  1/5521 (0.02%) 
Melena *  3/5521 (0.05%) 
Mucosal Tear / Laceration *  1/5521 (0.02%) 
Perforation *  1/5521 (0.02%) 
Stricture and/or dysphagia requiring dilatation *  2/5521 (0.04%) 
Upper GI Bleeding *  2/5521 (0.04%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%)
Total   42/5521 (0.76%) 
Injury, poisoning and procedural complications   
Catheter interaction with existing sutures *  1/5521 (0.02%) 
Dysphagia and/or Odynophagia *  4/5521 (0.07%) 
Esophageal spasms *  1/5521 (0.02%) 
Esophagitis and/or Ulceration *  4/5521 (0.07%) 
Hematemesis *  1/5521 (0.02%) 
Mallory-weiss tear *  1/5521 (0.02%) 
Mucosal Tear / Laceration *  14/5521 (0.25%) 
Mucosal trauma *  1/5521 (0.02%) 
Oxygen desaturation *  1/5521 (0.02%) 
Pain, Nausea, vomitting, fullness, abdominal discomfort *  12/5521 (0.22%) 
Prior Stricture worsen by RFA *  1/5521 (0.02%) 
Sizing Balloon did not work *  1/5521 (0.02%) 
Stricture - no dilatation *  12/5521 (0.22%) 
Stricture and/or dysphagia requiring dilatation *  37/5521 (0.67%) 
Stricture requiring dilatation- History EMR or Stricture *  2/5521 (0.04%) 
Upper GI Bleeding *  5/5521 (0.09%) 
*
Indicates events were collected by non-systematic assessment
Endoscopic clearance rate for Barrett's esophagus-Percentage of patients with no endoscopically visible Barrett's esophagus at 1 year follow-up: This endpoint is a visual and not reliable or accurate.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Nicholas Shaheen
Organization: University of north Carolina
Phone: (919) 966-7047
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT00848237     History of Changes
Other Study ID Numbers: B-500
First Submitted: December 20, 2007
First Posted: February 20, 2009
Results First Submitted: September 11, 2015
Results First Posted: February 5, 2016
Last Update Posted: February 5, 2016