Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 2

Conditions: Bariatric Endoscopy; Obesity & Overweight

Treatments: Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)

Study type: Interventional

Funder types: Other

Identifiers

NCT07612527

BEAM-GFMA

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Intervention arm

Experimental group

Treatment:

Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)