Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
Recruiting · NCT06757296 · Interventional (participants receive a specific treatment) · Lead sponsor: Singapore Health Services
View the official record on ClinicalTrials.gov →Interventions studied
Endoscopic SASI
What this trial 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.
Who can take part
Age range
21 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
3 locations listed.
- Changi General Hospital - Singapore, Singapore
- Sengkang General Hospital - Singapore, Singapore
- Singapore General Hospital - Singapore, Singapore