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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Excess Body Weight Loss After RFA Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
- •Subject is unable to provide informed consent for this study
结局指标
主要结局
Excess Body Weight Loss After RFA Treatment
时间窗: 12 months
EBWL 12 months after enrollment
次要结局
- Technical Feasibility: Percentage of Participants Who Completed RFA Treatment(Day 0, month 4, month 8)
- Patient Tolerability(12 months)
- Adverse Events(12 months)