Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Cairo University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Total body weight loss
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
Arms & Interventions
Intervention arm
Intervention: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) (Procedure)
Outcomes
Primary Outcomes
Total body weight loss
Time Frame: 6 months
BMI change from baseline
Time Frame: 6 months
Secondary Outcomes
- Gastric emptying time change from baseline(6 months)
- Gastric volume change from baseline(6 months)
- Fasting serum ghrelin change from baseline(6 months)
Investigators
Hany Shehab
Professor
Cairo University