Clinical trial NCT06622382: BEAM for Weight Loss - a Pilot Study
Official title: Bariatric Endoscopic Antral Myotomy (BEAM) for Weight Loss - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Body weight
timeFrame: baseline, 1,3,6,12 months
measure: Adverse events
timeFrame: within 30 days of procedure
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 day
measure: Serum ghrelin levels
timeFrame: baseline, 1,3,6,12 months
measure: Blood pressure
timeFrame: baseline, 1,3,6,12 months
measure: Lipid profile
timeFrame: baseline, 1,3,6,12 months
measure: Pain scale after procedure
timeFrame: 3 days
measure: Change in Quality of Life
timeFrame: baseline, 1,6,12 months
measure: Gastric emptying symptoms
timeFrame: baseline, 1,6,12 months
measure: Fasting glucose level
timeFrame: baseline, 1,3,6,12 months
measure: Insulin level
timeFrame: baseline, 1,3,6,12 months
measure: HbA1c level
timeFrame: baseline, 1,3,6,12 months
measure: serum liver parameters
timeFrame: baseline, 1,3,6,12 months
measure: hepatic steatosis index
timeFrame: baseline, 1,3,6,12 months
measure: NAFLD fibrosis
timeFrame: baseline, 1,3,6,12 months
measure: obstructive sleep apnea
timeFrame: baseline, 1,3,6,12 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Chinese University of Hong Kong
Study officials:
affiliation: Prince of Wales Hospital, the Chinese University of Hong Kong
name: Stephen Ng, FRCSEd(Gen)
role: PRINCIPAL_INVESTIGATOR
References: