Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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

Qualifiers

None

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators