Actively Recruiting
Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
Led by Chinese University of Hong Kong · Updated on 2024-10-02
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating bariatric endoscopic antral myotomy (BEAM), a new endoscopic technique for weight loss in obese patients eligible for endoscopic bariatric therapies. BEAM involves cutting muscle fibers in the gastric antrum to weaken the antral pump, delay gastric emptying, and help induce feelings of fullness. This pilot study aims to investigate the safety and effectiveness of BEAM, which may offer benefits such as lower risks, improved durability, and the ability to assess the stomach lining, which is important in regions with higher rates of gastric intestinal metaplasia or cancers. The procedure is performed using a gastroscope under general anesthesia. A mucosal incision is made at the incisura, followed by submucosal tunneling and partial thickness myotomy at the antrum near the pylorus, finishing with closure of the incision using endoclips. This intervention is studied as a single experimental arm. Participants will undergo the BEAM procedure, which is carefully monitored for technical success and safety. Participants will be followed over time with assessments at baseline and multiple points up to 12 months after the procedure. Measurements include body weight, adverse events within 30 days, blood tests (including ghrelin, glucose, insulin, lipid profile, liver parameters), quality of life, gastric emptying symptoms, blood pressure, and sleep apnea. Pain is assessed 3 days post-procedure. This comprehensive follow-up aims to evaluate both the effectiveness and safety of BEAM over one year.
CONDITIONS
Brief Title
BEAM for Weight Loss - a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Body mass index (BMI) of 30 kg/m2 or more (27.5 kg/m2 for Chinese or South Asian) up to 40 kg/m2, or BMI of 40 kg/m2 or more with high surgical risk or unwillingness to undergo surgery
- Failed standard obesity therapies including diet, exercise, behavior modification, and medications either alone or combined
You will not qualify if you...
- Previous upper gastrointestinal surgery (including bariatric, anti-reflux, gastrectomy, or esophageal surgery)
- Gastroparesis
- Active smoking
- Treatment with opioids in the last 12 months before enrollment
- Previous pyloromyotomy or pyloroplasty
- Gastrointestinal obstruction
- Use of medications that interfere with weight loss or gastric emptying
- Severe blood clotting disorders
- Esophageal or gastric varices or portal hypertensive gastropathy
- Uncontrolled endocrine disorders causing obesity (e.g., hypothyroidism, Cushing syndrome, eating disorders)
- Inflammatory diseases of the gastrointestinal tract (e.g., severe esophagitis, active ulcers, Crohn's disease)
- Malignancy
- Pregnant or breastfeeding
- Not fit for general anesthesia
- ASA grade IV or V
- Mental or psychiatric disorders; drug or alcohol addiction
- Other conditions deemed unsafe by the physician
- Refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and immediate recovery
Participants receive the bariatric endoscopic antral myotomy procedure which involves cutting muscle fibers in the gastric antrum to delay gastric emptying and induce satiety.
1 procedure visit (in-person) and 1 follow-up visit within 30 days
Duration - 12 months
Participants are monitored for body weight, serum ghrelin levels, blood pressure, lipid profiles, pain, quality of life, gastric emptying symptoms, glucose metabolism, liver parameters, and obstructive sleep apnea over 12 months after the procedure.
Visits at 1, 3, 6, and 12 months after treatment
Trial Site Locations
Total: 1 location
1
Chinese University of Hong Kong
Shatin, Hong Kong
Actively Recruiting
Research Team
S
Stephen Ng, FRCSEd(Gen)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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