Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

NCT07612527 | Not Yet Recruiting Phase 2

• 1 other identifier: BEAM-GFMA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity & Overweight; Bariatric Endoscopy

Outcome Measures

Primary Outcomes (2)

• Total body weight loss

  6 months

• BMI change from baseline

  6 months

Secondary Outcomes (3)

• Gastric emptying time change from baseline

  6 months

• Gastric volume change from baseline

  6 months

• Fasting serum ghrelin change from baseline

  6 months

Study Arms (1)

Intervention arm

EXPERIMENTAL

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

Interventions

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: 1. Submucosal injection by saline in the distal greater curvature about 8 cm proximal to the pylorus. 2. Using an ESD knife, a mucosal incision will be performed horizontally in the injected bleb 3. Submucosal tunneling down to the pyloric muscle 4. Partial thickness antral myotomy along the tunnel 1cm proximal to the pyloric muscle 5. Mucosal incision site will be sealed by endoscopic clips

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kar-Alaini hospital (Cairo Univeristy hospital)

Cairo, Egypt

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hany Shehab, MD, FRCP

CONTACT

+201111111071; h.shehab@kasralainy.edu.eg

Fatma Elrashdy

CONTACT

+201009454517; fatmaelrashdy@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)