A Phase 2 interventional study of Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) in Obesity & Overweight and Bariatric Endoscopy, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 10 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Body mass index (BMI) of ≥ 30 kg/m2 up to 40 kg/m2. 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:
Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)
All patients in intervention arm will undergo the following steps: A. GFMA: Injection of saline/methylene blue solution in the gastric fundal submucosa including the fundal dome and upper half of the greater curvature, sparing 1cm just below the cardia and the whole lesser curvature opposite this area. Argon plasma coagulation will then be applied to ablate the mucosa of this area using ERBE VIO3 generator with settings of Pulsed APC, Effect 2, flow rate 1 L/minutes, 50-60W to achieve a golden yellow discoloration of the mucosa B. BEAM will then be performed during the same exam as follows: 1. Submucosal injection by saline in the distal greater curvature about 8 cm proximal to the pylorus. 2. Using an ESD knife, a mucosal incision will be performed horizontally in the injected bleb 3. Submucosal tunneling down to the pyloric muscle 4. Partial thickness antral myotomy along the tunnel 1cm proximal to the pyloric muscle 5. Mucosal incision site will be sealed by endoscopic clips
Total body weight loss
Time frame: 6 months
BMI change from baseline
Time frame: 6 months
Gastric emptying time change from baseline
Time frame: 6 months
Gastric volume change from baseline
Time frame: 6 months
Fasting serum ghrelin change from baseline
Time frame: 6 months
Plan to share: No
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Cairo University