Health Trials

Bariatric Endoscopic Antral Myotomy Combined With Fundal Gastric Mucosal Ablation

ConditionsObesity & OverweightBariatric Endoscopy
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Procedure/Surgery

    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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Intervention armExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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