Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
Recruiting now · Not applicable
Conditions studied: Metabolic Syndrome, Severe Obesity, Reflux, Gastroesophageal, Bariatric Surgery
In brief
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.
Key facts
- Study ID
- NCT06757296
- Run by
- Singapore Health Services
- People needed
- 500
- Starts
- 2025-02-03
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-02-14
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must meet all the inclusion criteria to participate in this study and list each criterion.
- Age: 21-65 years
- Patients going for LSG at participating hospitals.
- 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.
You may not qualify if…
- Patients who were breast feeding or pregnant
- Severe psychiatric illness
- Eating disorder
- Active neoplastic disease
- End-stage renal disease
- Patients with bleeding diathesis
- Patients with pacemakers or implantable cardiac defibrillators
- Significant cardiovascular disease (e.g., acute myocardial infarction, congestive cardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome, supraventricular tachycardia)
- 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)
- Treatment with anti-platelet agents that could not be temporarily discontinued
Where it is running
- Changi General Hospital — Singapore, Singapore (enrolling)
- Sengkang General Hospital — Singapore, Singapore (enrolling)
- Singapore General Hospital — Singapore, Singapore (enrolling)
Full record on ClinicalTrials.gov
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