Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight; Bariatric Endoscopy
• Intervention / Treatment: Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hany Shehab, MD, FRCP; Phone Number: +201111111071; Email: h.shehab@kasralainy.edu.eg
• Study Contact Backup: Name: Fatma Elrashdy; Phone Number: +201009454517; Email: fatmaelrashdy@kasralainy.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Kar-Alaini hospital (Cairo Univeristy hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention arm

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total body weight loss	6 months
BMI change from baseline	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Gastric emptying time change from baseline	6 months
Gastric volume change from baseline	6 months
Fasting serum ghrelin change from baseline	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: BEAM-GFMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No