Obesity & OverweightPhase 2NCT07612527
Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation
A Phase 2 study testing Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) in people with Obesity & Overweight and Bariatric Endoscopy, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity & Overweight, Bariatric Endoscopy
- What is being tested?
- Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Aug 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kar-Alaini hospital (Cairo Univeristy hospital)
Cairo
hany shehab, h.shehab@drshehab.com
About this study
Official title: 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.
- Conditions
- Obesity & Overweight, Bariatric Endoscopy
- Being tested
- Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM)Procedure or surgery
All patients in intervention arm will undergo the following steps:
- 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
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body weight loss
Measured: 6 months
BMI change from baseline
Measured: 6 months
Secondary outcomes (3)
Gastric emptying time change from baseline
Measured: 6 months
Gastric volume change from baseline
Measured: 6 months
Fasting serum ghrelin change from baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start20 Aug 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Shehab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612527
- Sponsor's protocol ID
- BEAM-GFMA
- Status last verified
- Aug 2026
- First submitted
- 21 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation for The Management of Obesity
- ClinicalTrials.gov ID
- NCT07612527
- Acronym / sponsor ID
- BEAM-GFMA
- Conditions
- Obesity & Overweight, Bariatric Endoscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Procedure: Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: 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 | Procedure or surgery | Intervention arm |
Primary outcome
Total body weight loss
Time frame: 6 months
BMI change from baseline
Time frame: 6 months
3 secondary outcomes
Gastric emptying time change from baseline
Time frame: 6 months
Gastric volume change from baseline
Time frame: 6 months
Fasting serum ghrelin change from baseline
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gastric fundal mucosal ablation (GFMA), Bariatric endoscopic antral myotomy (BEAM) in people with Obesity & Overweight and Bariatric Endoscopy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany Shehab, MD, FRCP (+201111111071, h.shehab@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body weight loss (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.