Endoscopic conversion of sleeve gastrectomy to a new bypass method for reflux and obesity
Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
This study is testing a new, less invasive procedure to help people who haven't lost enough weight or have gained weight back after sleeve gastrectomy by converting it to a different type of bypass surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | Singapore Health Services Academic / other |
| Locations | 3 sites (Singapore and 2 other locations) |
| Trial ID | NCT06757296 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and effectiveness of an endoscopic procedure that converts sleeve gastrectomy to a single anastomosis sleeve-ileal bypass (SASI) using a lumen apposing metal stent (LAMS). It targets patients who have not achieved sufficient weight loss or have experienced weight regain after sleeve gastrectomy. The study proposes a less invasive, incisionless technique compared to traditional revisional laparoscopic surgeries, which carry higher risks of complications. By replicating the physiological effects of SASI, the study seeks to provide a safer alternative for patients struggling with metabolic syndrome and gastroesophageal reflux.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-65 who are undergoing sleeve gastrectomy and can provide informed consent.
Not a fit: Patients with severe psychiatric illnesses, active neoplastic diseases, or significant cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with obesity and gastroesophageal reflux who have not responded to previous bariatric surgery.
How similar studies have performed: While the SASI procedure is relatively novel, similar endoscopic techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subject must meet all the inclusion criteria to participate in this study and list each criterion. 1. Age: 21-65 years 2. Patients going for LSG at participating hospitals. 3. Able to provide informed consent Individuals below age 21 would not be recruited as this is a study in the adult population. Individuals above age 65 are excluded to minimize the procedure risk. Exclusion Criteria: 1. Patients who were breast feeding or pregnant 2. Severe psychiatric illness 3. Eating disorder 4. Active neoplastic disease 5. End-stage renal disease 6. Patients with bleeding diathesis 7. Patients with pacemakers or implantable cardiac defibrillators 8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia) 9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other or family members) 10. Treatment with anti-platelet agents that could not be temporarily discontinued
Where this trial is running
Singapore and 2 other locations
- Changi General Hospital — Singapore, Singapore (Recruiting)
- Sengkang General Hospital — Singapore, Singapore (Recruiting)
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Chin Hong Lim, MD — Singapore General Hospital
- Study coordinator: Chin Hong Lim, MD
- Email: lim.chin.hong@singhealth.com.sg
- Phone: 62223322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.