Use of Radiofrequency Ablation for RGB Salvage

Medtronic

Status: Completed

Conditions: Obesity

Treatments: Device: RFA treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01910688

B-600

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

RFA treatment (Radiofrequency ablation)

Experimental group

Description:

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.

Treatment:

Device: RFA treatment