BEAM for Weight Loss - a Pilot Study
Recruiting · NCT06622382 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
1 location listed.
- Chinese University of Hong Kong - Shatin, Hong Kong