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NCT Number: NCT06622382

BEAM for Weight Loss - a Pilot Study

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bariatric Endoscopic Antral Myotomy

Procedure

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 haemostasis is confirmed.

Primary outcomes

  1. Body weight

    Time frame: baseline, 1,3,6,12 months

    Weight change compared to baseline

  2. Adverse events

    Time frame: within 30 days of procedure

    Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

Secondary outcomes

  1. Technical success rate

    Time frame: 1 day

    successful completion of endoscopic procedures

  2. Serum ghrelin levels

    Time frame: baseline, 1,3,6,12 months

    Serum ghrelin levels compared to baseline

  3. Blood pressure

    Time frame: baseline, 1,3,6,12 months

    Blood pressure and anti-hypertensive medication use compared to baseline

  4. Lipid profile

    Time frame: baseline, 1,3,6,12 months

    Lipid profile compared to baseline

  5. Pain scale after procedure

    Time frame: 3 days

    measured by visual analogue scale (0:no pain - 10:worst pain)

  6. Change in Quality of Life

    Time frame: baseline, 1,6,12 months

    measured by 36-Item Short Form Survey (SF-36) questionnaire - (0:worst - 100:best)

  7. Gastric emptying symptoms

    Time frame: baseline, 1,6,12 months

    measured by gastroparesis cardinal symptom index (GCSI) - (0:best - 45:worst)

  8. Fasting glucose level

    Time frame: baseline, 1,3,6,12 months

    levels compared to baseline

  9. Insulin level

    Time frame: baseline, 1,3,6,12 months

    levels compared to baseline

  10. HbA1c level

    Time frame: baseline, 1,3,6,12 months

    levels compared to baseline

  11. serum liver parameters

    Time frame: baseline, 1,3,6,12 months

    AST, ALT, ALP and GGT level compared to baseline

  12. hepatic steatosis index

    Time frame: baseline, 1,3,6,12 months

    level compared to baseline

  13. NAFLD fibrosis

    Time frame: baseline, 1,3,6,12 months

    NAFLD fibrosis scores compared to baseline (F0: no liver fibrosis - F4: significant liver fibrosis)

  14. obstructive sleep apnea

    Time frame: baseline, 1,3,6,12 months

    Change in sleep quality

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen Ng, FRCSEd(Gen)

CONTACT

[email protected]

+85235052956

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: BEAM pilot

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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