Endoscopic RF Ablation after Weight Regain

Use of Endoscopically Delivered Radiofrequency Ablation for the Treatment of Patients Who Have Undergone Roux-en-Y Gastric Bypass and Have Failed to Achieve/ Maintain Satisfactory Excess Body Weight Loss

The purpose of this study is to determine the effectiveness of radiofrequency ablation, delivered via endoscopy, for the treatment of weight regain or inadequate weight loss after gastric bypass surgery. Individuals who have regained at least 25% of their lost weight or who did not lose at least 40% of their excess weight are eligible for this study.

Are you Eligible? (Inclusion Criteria)

Inclusion Criteria:

  • 18 Years to 70 Years
  • 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

Specialty Area(s)

Trial Location

United States