Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total body weight loss
研究概览
简要总结
The gastric fundus regulates appetite through orexigenic ghrelin-mediated and anorexigenic visceroceptive pathways. Accordingly, endoscopic gastric fundal mucosal ablation (GFMA) may benefit patients with obesity. Ablation not only affects these mechanisms, but similar to what happens after mucosal ablation for other indications (e.g. ESD for tumor removal), it is expected to cause shrinking of the fundus and reduce gastric volume.
Another potential target to achieve weight loss is gastric emptying. This is a critical step in digestion that has been found to be more rapid after prolonged exposure to a high-fat diet in both animal and human studies, with rapid emptying also being more common in young people with obesity in some studies. The bariatric endoscopic antral myotomy (BEAM) procedure has been shown to consistently delay gastric emptying without triggering symptoms of gastroparesis and to produce substantial weight loss.
Both GFMA and BEAM procedures have the advantages of being minimally invasive, performed completely endoscopic and less costly than surgical alternatives or other known endoscopic techniques like intragastric balloon or endoscopic sleeve gastroplasty.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of ≥ 30 kg/m2 up to 40 kg/m
- •BMI of 27.0 to 29.9 kg/m2 will be included on the condition of the presence of at least 1 obesity-related comorbidity (Indications based according to the American and European societies for bariatric endoscopy guidelines)
排除标准
- •Subjects with any previous surgeries to the stomach
- •Any previous bariatric procedures
- •Any current medications for the management of obesity (must be stopped at least 3 months before recruitment)
- •Evidence of severe gastritis, gastric peptic ulcer, or gastric cancer
- •Coagulopathy
- •Pregnancy
研究组 & 干预措施
Intervention arm
干预措施: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) (Procedure)
结局指标
主要结局
Total body weight loss
时间窗: 6 months
BMI change from baseline
时间窗: 6 months
次要结局
- Gastric emptying time change from baseline(6 months)
- Gastric volume change from baseline(6 months)
- Fasting serum ghrelin change from baseline(6 months)
