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Recruiting NCT07612527

Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

Conditions: Obesity & Overweight, Bariatric Endoscopy

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: Cairo University

Location: Kar-Alaini hospital (Cairo Univeristy hospital) Cairo

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.

Eligibility Criteria

Inclusion Criteria: 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: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07612527). StuddyBuddy aggregates publicly available trial information.