Use of Radiofrequency Ablation for RGB Salvage

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 gastric bypass (RGB) and laparoscopic adjustable gastric band
placement. Despite the overall initial success of RGB to induce significant EBWL in the
majority of patients, significant weight regain occurs in about 25% of patients at 2+ years
following surgery. Given the preliminary success of endoscopic, non-surgical salvage
interventions for the failed (uncomplicated) RGB patient, 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. A reduction of
size and compliance may, as others have reported, result in re-establish weight loss and
achieve an acceptable EBWL with minimal patient morbidity.

Inclusion Criteria:

1. History of RGB surgery at least 1 year prior to enrollment

2. Achievement of > 40% EBWL after RGB

3. 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

4. Age 18-70 inclusive

5. Subject is able to tolerate endoscopy and sedation

6. Subject agrees to participate, fully understands content of the informed consent, and
signs the informed consent form (ICF)

Exclusion Criteria:

1. History of any bariatric surgery other than RGB, including lap band

2. History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration

3. Gastrojejunostomy > 4 cm in diameter (size estimated at time of endoscopy)

4. Perceived inability of the patient by the Investigator to comply with a
post-treatment diet or medication regimen

5. History of alcohol, tobacco and/or controlled substance dependency that would impair
the patient from complying with protocol requirements

6. Pregnancy

7. Subject is unable to provide informed consent for this study