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NCT Number: NCT07612527

Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

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.

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Key information

Conditions

Obesity & Overweight Bariatric Endoscopy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kar-Alaini hospital (Cairo Univeristy hospital)

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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:

  • Submucosal injection by saline in the distal greater curvature about 8 cm proximal to the pylorus.
  • Using an ESD knife, a mucosal incision will be performed horizontally in the injected bleb
  • Submucosal tunneling down to the pyloric muscle
  • Partial thickness antral myotomy along the tunnel 1cm proximal to the pyloric muscle
  • Mucosal incision site will be sealed by endoscopic clips

Primary outcomes

  1. Total body weight loss

    Time frame: 6 months

  2. BMI change from baseline

    Time frame: 6 months

Secondary outcomes

  1. Gastric emptying time change from baseline

    Time frame: 6 months

  2. Gastric volume change from baseline

    Time frame: 6 months

  3. Fasting serum ghrelin change from baseline

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Elrashdy

CONTACT

[email protected]

+201009454517

Hany Shehab, MD, FRCP

CONTACT

[email protected]

+201111111071

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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