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Recruiting NCT06757296

Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

Trial Parameters

Condition Metabolic Syndrome
Sponsor Singapore Health Services
Study Type INTERVENTIONAL
Phase N/A
Enrollment 500
Sex ALL
Min Age 21 Years
Max Age 65 Years
Start Date 2025-02-03
Completion 2026-08-30
Interventions
Endoscopic SASI

Brief Summary

The aim of this study is to determine the feasibility and effectiveness of endoscopic anastomosis of sleeve gastrectomy to ileum with a lumen apposing metal stent (LAMS) after a failed sleeve gastrectomy.

Eligibility 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 medi

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