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Recruiting NCT06622382

BEAM for Weight Loss - a Pilot Study

No phase Interventional Obesity and Obesity-related Medical Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric endoscopic antral myotomy.
Who it may be relevant to
Registry conditions: Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study

Overview

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.

Interventions

  • Procedure Bariatric endoscopic antral myotomy
    A mucosal incision is performed using a triangle-tip knife J at the level of the incisura along the level of the greater curvature. Submucosal tunneling is then performed and stopped immediately proximal to the pylorus. Two parallel lines of partial thickness myotomy are then performed from the distal to proximal antrum using the same endoscopic knife. The myotomy is stopped approximately 2 cm distal to the mucosal incision site. Finally, the mucosal incision is closed using endoclips after haem

Primary outcome measures

  • Body weight [Time frame: baseline, 1,3,6,12 months]
  • Adverse events [Time frame: within 30 days of procedure]
Secondary outcome measures (12)
  • Technical success rate [Time frame: 1 day]
  • Serum ghrelin levels [Time frame: baseline, 1,3,6,12 months]
  • Blood pressure [Time frame: baseline, 1,3,6,12 months]
  • Lipid profile [Time frame: baseline, 1,3,6,12 months]
  • Pain scale after procedure [Time frame: 3 days]
  • Change in Quality of Life [Time frame: baseline, 1,6,12 months]
  • Gastric emptying symptoms [Time frame: baseline, 1,6,12 months]
  • Fasting glucose level [Time frame: baseline, 1,3,6,12 months]
  • Insulin level [Time frame: baseline, 1,3,6,12 months]
  • HbA1c level [Time frame: baseline, 1,3,6,12 months]
  • serum liver parameters [Time frame: baseline, 1,3,6,12 months]
  • hepatic steatosis index [Time frame: baseline, 1,3,6,12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT06622382 · CRE-2024.223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗