| NCT ID | NCT06622382 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Obesity and Obesity-related Medical Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-09-12 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2024-09-12 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Bariatric endoscopic antral myotomy (BEAM) is a novel endoscopic technique which is performed using a gastroscope under general anesthesia. It involves cutting the muscle fibers at the gastric antrum, thereby weakening the antral pump, delaying gastric emptying and inducing satiety. Early reports had shown that this technique can produce significant weight loss. Furthermore, this technique has the potential benefits of lower risks, improved durability and allows subsequent mucosal assessment of stomach, which is important in Asia countries with higher prevalence of gastric intestinal metaplasia or gastric cancers. Given that this novel endoscopic technique has not been widely adopted for treatment of obesity, this pilot study aims to investigate the efficacy and safety of BEAM in obese patients who are eligible for endoscopic bariatric therapies.
Eligibility 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
Contact & Investigator
Stephen Ng, FRCSEd(Gen)
PRINCIPAL INVESTIGATOR
Prince of Wales Hospital, the Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06622382 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity and Obesity-related Medical Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06622382 currently recruiting?
Yes, NCT06622382 is actively recruiting participants. Contact the research team at stephenng@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06622382 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06622382 clinical trial?
NCT06622382 is sponsored by Chinese University of Hong Kong. The principal investigator is Stephen Ng, FRCSEd(Gen) at Prince of Wales Hospital, the Chinese University of Hong Kong. The trial plans to enroll 10 participants.
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