EndoRotor for Refractory BE
Research type
Research Study
Full title
PROSPECTIVE, RANDOMIZED TRIAL COMPARING THE SAFETY AND EFFECTIVENESS OF THE INTERSCOPE ENDOROTOR® MUCOSAL RESECTION SYSTEM WITH CONTINUED ABLATIVE THERAPY IN SUBJECTS WITH REFRACTORY DYSPLASTIC BARRETT'S ESOPHAGUS
IRAS ID
243999
Contact name
Rehan Haidry
Contact email
Sponsor organisation
Interscope, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This is a prospective, multi-center, randomized study to compare the safety and performance of the EndoRotor® Mucosal Resection System with continued ablative therapy in subjects with refractory dysplastic Barrett's Esophagus. Subjects must have failed 3 RFA treatments (failure of Barrett's to respond to RFA with a decrease of at least 50% of its length) and following 3 RFA failures have no endoscopic and histologic evidence of esophageal adenocarcinoma at the time of therapy. The subjects are randomized and treated (up to 2 times) with either the EndoRotor® which resects the affected mucosa and submucosa (down to the muscularis propria layer), or with cryotherapy or ablative therapy of the persistent lesions. Subjects will be followed with biopsies of the resected areas at the time of surveillance endoscopies every 3 months until they have 2 consecutive negative endoscopies and biopsies (6 months).
The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1407
Date of REC Opinion
17 Oct 2018
REC opinion
Further Information Favourable Opinion