| NCT ID | NCT06790329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Obesity and Obesity-related Medical Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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
Contact & Investigator
Stephen Ng, FRCSEd(Gen)
PRINCIPAL INVESTIGATOR
Prince of Wales Hospital, the Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06790329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Obesity and Obesity-related Medical Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06790329 currently recruiting?
Yes, NCT06790329 is actively recruiting participants. Contact the research team at stephenng@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT06790329 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06790329 clinical trial?
NCT06790329 is sponsored by Chinese University of Hong Kong. The principal investigator is Stephen Ng, FRCSEd(Gen) at Prince of Wales Hospital, the Chinese University of Hong Kong. The trial plans to enroll 10 participants.
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