Clinical trial

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 · 1 countries · Registry ID NCT06757296

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age21 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionMetabolic Syndrome, Severe Obesity, Reflux, Gastroesophageal, Bariatric Surgery

Full registry 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

Treatments and study arms

Endoscopic SASI

Procedure

Endoscopic conversion to sleeve gastrectomy to SASI

Primary outcomes

Total amount of weight loss6 months

Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Changi General Hospital🇸🇬 Singapore, Singapore
Jinlin Lin, MDContact
Jinlin Lin, MDPrincipal Investigator
Sengkang General Hospital🇸🇬 Singapore, Singapore
Baldwin Po Man Yeung, MDContact
Baldwin Po Man Yeung, MDPrincipal Investigator
Singapore General Hospital🇸🇬 Singapore, Singapore
Chin Hong Lim, MDContact
Wei Min Chong, MScContact
Chin Hong Lim, MDPrincipal Investigator