NCT06790329Recruiting

ESG With Fundal Mucosal Ablation

Endoscopic Sleeve Gastroplasty With Fundal Mucosal Ablation - a Pilot Study

Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Endoscopic sleeve gastroplasty (ESG) have emerged as an effective primary endoscopic therapy for weight loss. While ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus and therefore does not lead to decrease in fasting plasma ghrelin after procedure. Recently, a new endoscopic technique involving the ablation of the gastric fundus has been developed, showing promising results with a reduction in fasting plasma ghrelin levels and a mean total body weight loss of 7.7%. Combining endoscopic gastric fundus mucosal ablation with ESG could potentially enhance the weight loss effects of ESG while maintaining an acceptable safety profile. This pilot study aims to evaluate the efficacy, safety, and physiological effects of combining endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA) in obese patients eligible for endoscopic bariatric therapies.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 10 (estimated)
First submitted: 17 Jan 2025
Start date: 1 Jan 2025
Primary completion date: 31 Dec 2026
Lead sponsor: Chinese University of Hong Kong
Diseases: Obesity
NCT number: NCT06790329

What you commit to

Study type: Interventional
Planned participants: 10
From 1 Jan 2025 to the primary completion date, 31 Dec 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous upper GI surgery (e.g. bariatric surgery, anti-reflux surgery; gastrectomy; esophageal surgery)
Previous ESG
An ongoing or a history of treatment with opioids in the last 12 months prior to enrollment
Previous pyloromyotomy or pyloroplasty
Use of any medication that may interfere with weight loss or gastric emptying

Other illness

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
Mental or psychiatric disorder; Drug or alcohol addiction

Other

Gastroparesis
Active smoking
Gastrointestinal obstruction
Severe coagulopathy
Esophageal or gastric varices and/or portal hypertensive gastropathy
Pregnant or breast feeding
Patients not fit for general anesthesia
ASA grade IV or V
Other cases deemed by the examining physician as unsuitable for safe treatment
Refusal to participate

Who the study is looking for

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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Chinese University of Hong Kong Coordinator of this site? Confirm its status	Shatin	Hong Kong SAR China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.