Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06622382

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

106 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

BEAM for Weight Loss - a Pilot Study

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Body mass index (BMI) of 30 kg/m2 or higher (27.5 kg/m2 or higher for Chinese or South Asian) up to 40 kg/m2, or BMI 40 kg/m2 or more with high surgical risk or unwillingness to undergo surgery
  • Failed standard obesity treatments including diet, exercise, behavior changes, and weight loss medications alone or combined
Not Eligible

You will not qualify if you...

  • Previous upper gastrointestinal surgery such as bariatric surgery, anti-reflux surgery, gastrectomy, or esophageal surgery
  • Gastroparesis
  • Current active smoking
  • Treatment with opioids within the last 12 months
  • Previous pyloromyotomy or pyloroplasty
  • Gastrointestinal obstruction
  • Use of medications that affect 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 including severe esophagitis, active gastric or duodenal ulcers, or Crohn's disease
  • Cancer
  • Pregnancy or breastfeeding
  • Not fit for general anesthesia
  • American Society of Anesthesiologists (ASA) grade IV or V
  • Mental or psychiatric disorders; drug or alcohol addiction
  • Any other condition considered unsafe by the physician
  • Refusal to participate

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Chinese University of Hong Kong

Shatin, Hong Kong

Actively Recruiting

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Research Team

S

Stephen Ng, FRCSEd(Gen)

CONTACT

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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