Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06790329

ESG With Fundal Mucosal Ablation

Led by Chinese University of Hong Kong · Updated on 2025-01-24

10

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

ESG With Fundal Mucosal Ablation

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination
  • Age between 18 and 70 years
Not Eligible

You will not qualify if you...

  • Previous upper GI surgery such as bariatric surgery, anti-reflux surgery, gastrectomy, or esophageal surgery
  • Previous endoscopic sleeve gastroplasty (ESG)
  • Gastroparesis
  • Active smoking
  • Treatment with opioids in the last 12 months prior to enrollment
  • Previous pyloromyotomy or pyloroplasty
  • Gastrointestinal obstruction
  • Use of any medication interfering with weight loss or gastric emptying
  • Severe coagulopathy
  • Esophageal or gastric varices and/or portal hypertensive gastropathy
  • Uncontrolled endocrine problems causing obesity (e.g., hypothyroidism, Cushing syndrome, eating disorder)
  • Inflammatory diseases of the gastrointestinal tract including severe esophagitis, active gastric or duodenal ulcers, Crohn's disease
  • Malignancy
  • Pregnant or breastfeeding
  • Not fit for general anesthesia
  • ASA grade IV or V
  • Mental or psychiatric disorders; drug or alcohol addiction
  • Other conditions deemed unsuitable for safe treatment by physician
  • Refusal to participate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chinese University of Hong Kong

Shatin, Hong Kong

Actively Recruiting

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Research Team

S

Stephen Ng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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