Status:
COMPLETED
Use of Radiofrequency Ablation for RGB Salvage
Lead Sponsor:
Medtronic - MITG
Conditions:
Obesity
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased complianc...
Detailed Description
Obesity is a leading cause of preventable death in the United States, with approximately 300,000 related deaths per year. The most commonly performed bariatric surgical interventions are Roux-en Y gas...
Eligibility Criteria
Inclusion
- History of RGB surgery at least 1 year prior to enrollment
- Achievement of \> 40% EBWL after RGB
- Weight regain of \> 25% of the lost weight at the time of enrollment. For example, if excess body weight was 50 kg prior to RGB, patient must have lost at least 20 kg after RGB, then regained at least 5 kg to be eligible for the present study
- Age 18-70 inclusive
- Subject is able to tolerate endoscopy and sedation
- Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF)
Exclusion
- History of any bariatric surgery other than RGB, including lap band
- History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration
- Gastrojejunostomy \> 4 cm in diameter (size estimated at time of endoscopy)
- Perceived inability of the patient by the Investigator to comply with a post-treatment diet or medication regimen
- History of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements
- Pregnancy
- Subject is unable to provide informed consent for this study
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01910688
Start Date
July 1 2013
End Date
January 1 2016
Last Update
June 24 2016
Active Locations (2)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
2
Columbia Univeristy
New York, New York, United States, 10032