Study:
Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia Trial) A Multi-center, Randomized, Sham-Controlled Trial: Protocol Amendment to Extend Follow-up to 5 Years
Rationale:
n/a
Purpose:
The purpose of this study is to determine if the intervention of a 510(k)-cleared
endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy
is better than anti-secretory therapy alone in clearing Barrett`s Esophagus.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Barrett Esophagus |
Device: Ablation System plus anti-secretory medication Device: Sham procedure plus anti-secretory medication |
N/A |
Verified by
BÂRRX Medical, Inc.
July, 2012
Sponsored by: BÂRRX Medical, Inc.
Information provided by: BÂRRX Medical, Inc.
ClinicalTrials.gov identifier: NCT00282672
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
David S. Utley, MD., Study Director