Bariatric endoscopic antral myotomy for weight loss
Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
This study is testing a new, less invasive procedure called bariatric endoscopic antral myotomy to see if it can help people with obesity lose weight by making them feel fuller for longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT06622382 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the efficacy and safety of a novel endoscopic technique called bariatric endoscopic antral myotomy (BEAM) for weight loss in obese patients. The procedure involves cutting muscle fibers in the gastric antrum to delay gastric emptying and induce feelings of fullness. It is performed under general anesthesia using a gastroscope and aims to provide a less invasive option for patients who have not succeeded with traditional obesity treatments. The study will assess the potential benefits of BEAM, particularly in regions with higher risks of gastric conditions.
Who should consider this trial
Good fit: Ideal candidates include obese individuals with a BMI of 30 or higher who have failed standard obesity therapies and are either high-risk for surgery or unwilling to undergo surgical options.
Not a fit: Patients with previous upper gastrointestinal surgeries, active smoking habits, or certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could offer a safer and more effective weight loss solution for obese patients who are not candidates for traditional surgery.
How similar studies have performed: While this specific technique is novel and has not been widely adopted, early reports suggest it may produce significant weight loss, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI equal or more than 30kg/m2 (27.5kg/m2 for Chinese or South Asian) to 40kg/m2, or BMI equal or more than 40kg/m2 and patient is either high risk for surgery or unwilling to undergo surgery, AND * failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination Exclusion Criteria: * Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery) * Gastroparesis * Active smoking * An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment * Previous pyloromyotomy or pyloroplasty * Gastrointestinal obstruction * Use of any medication that may interfere with weight loss or gastric emptying * Severe coagulopathy * Esophageal or gastric varices and/or portal hypertensive gastropathy * Underlying uncontrolled endocrine problem that leads to obesity. (e.g. Hypothyroidism, Cushing syndrome, eating disorder etc.) * Any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease) * Malignancy * Pregnant or breast feeding * Patients not fit for general anesthesia * ASA grade IV or V * Mental or psychiatric disorder; Drug or alcohol addiction * Other cases deemed by the examining physician as unsuitable for safe treatment * Refusal to participate
Where this trial is running
Shatin
- Chinese University of Hong Kong — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Stephen Ng, FRCSEd(Gen) — Prince of Wales Hospital, the Chinese University of Hong Kong
- Study coordinator: Stephen Ng, FRCSEd(Gen)
- Email: stephenng@surgery.cuhk.edu.hk
- Phone: +85235052956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.