NCT06757296

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Singapore Health Services · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current standard of care for patients who experience insufficient weight loss, weight re-gain or Type II diabetes relapse after a sleeve gastrectomy is a revisional laparoscopic sleeve gastrectomy. However, such revisional procedure is commonly associated with high mortality and morbidity due to protein malnutrition. A noval bariatric procedure, single anastomosis sleeve ileal (SASI) bypass has emerged recently. In this study, we are utilizing an incisionless novel endoscopic technique to efficiently replicate the anatomical features and physiological effects of SASI.

Conditions

• Metabolic Syndrome
• Severe Obesity
• Reflux, Gastroesophageal
• Bariatric Surgery

Interventions

Type	Name	Description
PROCEDURE	Endoscopic SASI	Endoscopic conversion to sleeve gastrectomy to SASI

Timeline

• Start date: 2025-02-03
• Primary completion: 2026-08-30
• Completion: 2026-12-31
• First posted: 2025-01-03
• Last updated: 2025-02-14

Locations

3 sites across 1 country: Singapore