Actively Recruiting
Endoscopic Sleeve Gastroplasty with Fundal Mucosal Ablation Pilot Study Evaluating Weight Loss Effects in Obesity
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
Researchers are evaluating a new combined endoscopic treatment for obesity called endoscopic sleeve gastroplasty with fundal mucosal ablation (ESG-FUMA). This pilot study aims to assess the effectiveness, safety, and biological effects of this combined procedure in obese patients who qualify for endoscopic bariatric therapies. The study addresses the limitation that ESG alone does not reduce fasting plasma ghrelin levels, which may affect weight loss outcomes compared to laparoscopic sleeve gastrectomy. The treatment involves two steps: first, mucosal ablation around the gastric fundus is performed using a hybrid argon plasma coagulation probe after injecting saline beneath the mucosa to prepare the area. Next, endoscopic sleeve gastroplasty is carried out by placing 6 to 8 permanent full-thickness sutures along the greater curvature of the stomach, sparing the fundus. The procedure is completed once bleeding is controlled and hemostasis is confirmed. Participants will be monitored for weight changes at baseline and at 1, 3, 6, and 12 months after treatment. Researchers will also assess safety and physiological responses associated with the procedure. Total body weight loss and changes in fasting plasma ghrelin levels will be key measures to evaluate the combined treatment's effects over time.
CONDITIONS
Official Title
ESG With Fundal Mucosal Ablation
Who Can Participate
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Chinese University of Hong Kong
Shatin, Hong Kong
Actively Recruiting
Research Team
S
Stephen Ng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here