Use of Radiofrequency Ablation for RGB Salvage

N/ACompletedNCT01910688

Medtronic - MITG25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

RFA treatmentDEVICE

If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Columbia Univeristy

New York, New York, United States

Outcomes

Primary Outcomes

Excess Body Weight Loss After RFA Treatment

EBWL 12 months after enrollment

Time frame: 12 months

Secondary Outcomes

Technical Feasibility: Percentage of Participants Who Completed RFA Treatment

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.

Time frame: Day 0, month 4, month 8

Patient Tolerability

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.

Time frame: 12 months

Adverse Events

Adverse event profile: Relationship to study device : Definite, Probable, Possible

Time frame: 12 months

Data from ClinicalTrials.gov

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