Endoscopic sleeve gastroplasty with fundal mucosal ablation for weight loss

Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study

This study is testing a new weight loss method that combines a procedure called endoscopic sleeve gastroplasty with a technique to reduce a hormone that makes you feel hungry, to see if it helps people lose more weight safely.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chinese University of Hong Kong (other)
• Locations: 1 site (Shatin)
• Trial ID: NCT06790329 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the effectiveness and safety of combining endoscopic sleeve gastroplasty (ESG) with a new technique of fundal mucosal ablation to enhance weight loss outcomes. ESG is a minimally invasive procedure that mimics the effects of gastric sleeve surgery but traditionally does not affect the gastric fundus, which is linked to ghrelin production. By incorporating fundal ablation, the study aims to reduce fasting plasma ghrelin levels and improve weight loss results. Participants will be monitored for both physiological effects and overall safety during the intervention.

Who should consider this trial

Good fit: Ideal candidates include individuals with a BMI of 30-40 kg/m2 who have failed standard obesity treatments and are either high-risk for surgery or unwilling to undergo surgical options.

Not a fit: Patients with previous upper gastrointestinal surgeries or those with certain medical conditions such as severe coagulopathy or uncontrolled endocrine disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective weight loss solutions for patients struggling with obesity.

How similar studies have performed: While ESG has shown promise, the combination with fundal mucosal ablation is a novel approach that has not been extensively tested in previous studies.

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)
* Previous ESG
* 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

Where this trial is running

Shatin

• Chinese University of Hong Kong — Shatin, Hong Kong (RECRUITING)

Study contacts

• Principal investigator: Stephen Ng, FRCSEd(Gen) — Prince of Wales Hospital, the Chinese University of Hong Kong
• Study coordinator: Stephen Ng

Conditions: Obesity and Obesity-related Medical Conditions