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NCT00489268 · ClinicalTrials.gov registry record · NA
Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years
A NA study of Barrett Esophagus, sponsored by Covidien, GI Solutions.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 10
- Study locations
NCT00489268: Completed NA study of Barrett Esophagus, sponsored by Covidien, GI Solutions.
NCT00489268 is a NA study of Barrett Esophagus that has completed, run by Covidien, GI Solutions. The registered enrollment target is 102 participants, below the 3,562-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00489268, a NA study of Barrett Esophagus, has completed, sponsored by Covidien, GI Solutions.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 10
- Study locations
Study Summary
This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to 12 J/cm2. The effectiveness phase used 10 J/cm2 delivered twice for all patients, followed by Esophagogastroduodenoscopy (EGD) with biopsies at 1, 3, 6, and 12 months. A second ablation procedure was performed if Barretts esophagus (BE) was present at 1 or 3 months. A complete response (CR) was defined as all biopsy specimens negative for Barrett's Esophagus at 12 months. The effectiveness phase of the present study was extended to a 2.5-year follow-up. This trial incorporated an opportunity for persistent BE to be treated with a focal ablation device (HALO90), achieving a CR in 98.4% of patients by the 2.5-year follow-up,the results of which were published . There is ample evidence that RadioFrequency Ablation (RFA) for Barrett's esophagus is effective and safe. Having additional follow-up (5 years) would add valuable information to the literature, thus aiding the physician in making patient management decisions about the appropriate follow-up interval after RFA.
Primary Outcome
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).
Conditions Studied
Interventions
- DEVICE HALO Ablation System
Study Locations (10)
Arizona
- Mayo Clinic Scottsdale - Scottsdale
California
- UC Irvine Medical Center - Orange
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Minnesota
- Mayo Clinic Rochester - Rochester
New York
- Columbia University Medical Center - New York
Oregon
- Oregon Health Sciences University - Portland
Pennsylvania
- University of Pennsylvania - Philadelphia
Tennessee
- Gastrointestinal Associates - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2003-11 |
| Est. Completion | 2009-10 |
| Phase | NA |
What the finished NCT00489268 record still lists
NCT00489268 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 3,562-participant average among 32 other Barrett Esophagus trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Barrett Esophagus appearing as the primary indexed condition, and to 1 intervention - of which HALO Ablation System is the first listed.
NCT00489268 lists 10 locations in 10 states (Arizona, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT00489268 about?
NCT00489268 is a clinical study titled "Micro-Layer Ablation of Barrett's Metaplasia- A Two-Phase, Multi-Center Trial - Extension of Follow-up to 5 Years". This study was conducted in 2 serial phases (dosimetry phase and effectiveness phase) to evaluate a balloon-based ablation device (HALO360) that delivers a pre-set amount of energy density (J/cm2) to barrett's tissue. The dosimetry phase evaluated the dose-response and the safety of delivering 6 to ...
What is the current status of trial NCT00489268?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2003-11. Estimated completion is 2009-10.
What conditions does trial NCT00489268 study?
This clinical trial studies the following conditions: Barrett Esophagus.
What interventions are being tested in trial NCT00489268?
The interventions under investigation include: HALO Ablation System (DEVICE).
Who is sponsoring clinical trial NCT00489268?
This trial is sponsored by Covidien, GI Solutions, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00489268 being conducted?
This trial has 10 study locations across Arizona, California, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Barrett Esophagus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00489268's enrollment target sits among peer trials
102 20th of 32 higher than 13 of 32 other Barrett Esophagus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Barrett Esophagus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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