跳至主要内容
临床试验/NCT07612527
NCT07612527招募中2 期

Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity

Cairo University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年8月20日最近更新:
适应症
干预措施

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

Experimental

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hany Shehab

Professor

Cairo University

研究点 (1)

Loading locations...

相似试验