Use of Radiofrequency Ablation for RGB Salvage

Not Applicable

Completed

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 compliance after a failed Roux-en-Y gastric bypass.

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 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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
RFA treatment (Radiofrequency ablation)	RFA treatment	If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.

Primary Outcome Measures

Name	Time	Method
Excess Body Weight Loss After RFA Treatment	12 months	EBWL 12 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Technical Feasibility: Percentage of Participants Who Completed RFA Treatment	Day 0, month 4, month 8	Technical feasibility of applying RFA to gastric pouch and gastrojejunostomy. This will be assessed by asking the physician for feedback on ease of use, ease of intubation and extubation,did the physician achieve tissue contact in targeted areas, was targeted area successfully ablated.
Patient Tolerability	12 months	Patient tolerability of the procedure. Patient tolerability will be measured by assessing adverse events related to the device or procedure. The Investigator will assess each adverse event with respect to severity and relationship to the study device.
Adverse Events	12 months	Adverse event profile: Relationship to study device : Definite, Probable, Possible

Locations (2): Columbia Univeristy
🇺🇸
New York, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States