Use of Radiofrequency Ablation for RGB Salvage
Completed · Not applicable
Conditions studied: Obesity
In brief
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 compliance after a failed Roux-en-Y gastric bypass.
Key facts
- Study ID
- NCT01910688
- Run by
- Medtronic - MITG
- People needed
- 25
- Starts
- 2013-07-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-06-24
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Columbia Univeristy — New York, New York, United States
Full record on ClinicalTrials.gov
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