BEAM for Weight Loss - a Pilot Study

NCT06622382 | Recruiting

• 1 other identifier: CRE-2024.223
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (2)

• Body weight

  Weight change compared to baseline

  baseline, 1,3,6,12 months

• Adverse events

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

  within 30 days of procedure

Secondary Outcomes (14)

• Technical success rate

  1 day

• Serum ghrelin levels

  baseline, 1,3,6,12 months

• Blood pressure

  baseline, 1,3,6,12 months

• Lipid profile

  baseline, 1,3,6,12 months

• Pain scale after procedure

  3 days

Study Arms (1)

Bariatric endoscopic antral myotomy

EXPERIMENTAL

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.

Procedure: Bariatric endoscopic antral myotomy

Interventions

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.

Bariatric endoscopic antral myotomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Ng, FRCSEd(Gen)

  Prince of Wales Hospital, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Ng, FRCSEd(Gen)

CONTACT

+85235052956; stephenng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: October 2, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

HK (1)