NCT01910688

Use of Radiofrequency Ablation for RGB Salvage

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DEVICE	RFA treatment	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.

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-07-30
• Last updated: 2016-06-24
• Results posted: 2016-06-24

Locations

2 sites across 1 country: United States