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

Date de début de l'étude : 1 novembre 2003

Inclusion Criteria: 1. 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 2. Barrett metaplasia endoscopic length: Phase I : 2-3 cm Barrett's length (inclusive) Phase II: 2-6 cm Barrett's length (inclusive) 3. Age 18-75 years inclusive 4. Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form 5. 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. Exclusion Criteria: 1. Subjects is pregnant or planning a pregnancy 2. Esophageal stricture preventing passage of endoscope or catheter 3. Active esophagitis (Hetzel-Dent Grade III or IV) described as erosions or ulcerations encompassing more than 10% of distal esophagus 4. Barrett's metaplasia with dysplasia (any previous biopsy) 5. History or current diagnosis of malignancy of the esophagus 6. Prior radiation therapy to the esophagus, except head and neck region radiation therapy 7. Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) 8. Any previous endoscopic mucosal resection within the esophagus 9. Any previous esophageal surgery, except fundoplication 10. Esophageal varices 11. 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 12. Participation in another clinical study in past 60 days 13. Subject suffers from unstable psychiatric disorder(s)