Endoscopic sleeve gastroplasty with fundal mucosal ablation for weight loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: stephenng@surgery.cuhk.edu.hk
• Phone: (852)35052956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.