ESG with Fundal Mucosal Ablation (ESG-FUMA)

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Obesity and Obesity-related Medical Conditions

Treatments

Procedure: Endoscopic sleeve gastroplasty with fundal mucosal ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT06790329

CRE-2024.501

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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