ESG With Fundal Mucosal Ablation
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 betwe
| Condition(s) | Obesity and Obesity-related Medical Conditions |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 ef |
| Who can participate | 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 * Esop |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Chinese University of Hong Kong |
| Locations | Shatin, Hong Kong |
| Start date | 2025-01-01 |
| NCT ID | NCT06790329 |
| Official listing | https://clinicaltrials.gov/study/NCT06790329 |