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

Completed · Not applicable

Conditions studied: Barrett Esophagus

In brief

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.

Key facts

Study ID

NCT00489268

Run by

Covidien, GI Solutions

People needed

102

Starts

2003-11-01

Expected to finish

2009-10-01

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has documented histopathological diagnosis of Barrett's metaplasia (without dysplasia) as follows:
• biopsies obtained less than 6 months prior to enrollment, and
• biopsies obtained and reviewed at the investigator institution, and
• biopsy protocol included at least 4 quadrant biopsies per 2 cm length of Barrett's metaplasia
• Barrett metaplasia endoscopic length:
• Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive)
• Age 18-75 years inclusive
• Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
• Five year extension: All subjects who participated in B-200-2.5 year extension and had a biopsy at 2.5 years after initial enrollment (n=61) will be offered participation in this extension.

You may not qualify if…

• Subjects is pregnant or planning a pregnancy
• Esophageal stricture preventing passage of endoscope or catheter
• Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus
• Barrett's metaplasia with dysplasia (any previous biopsy)
• History or current diagnosis of malignancy of the esophagus
• Prior radiation therapy to the esophagus, except head and neck region radiation therapy
• Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other)
• Any previous endoscopic mucosal resection within the esophagus
• Any previous esophageal surgery, except fundoplication
• Esophageal varices
• Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device
• Participation in another clinical study in past 60 days
• Subject suffers from unstable psychiatric disorder(s)

Where it is running

• Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
• UC Irvine Medical Center — Orange, California, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Gastrointestinal Associates — Knoxville, Tennessee, United States
• Tacoma Digestive Disease and Research Center — Seattle, Washington, United States
• Ponce Gastroenterology Research — Ponce, Puerto Rico

Full record on ClinicalTrials.gov

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