Tests an endoscopic bypass for reflux after failed sleeve gastrectomy in adults with obesity
Tests an endoscopic bypass procedure in adults with obesity and reflux after sleeve surgery.
Plain-language title generated from the registry record
Registry title: Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
Key facts
- Where
- Singapore, SingaporeSee the 3 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 65 years old?
Source: NCT06757296, who can take part
Where in Singapore
- Changi General HospitalSingapore, SingaporeTaking people
- Sengkang General HospitalSingapore, SingaporeTaking people
- Singapore General HospitalSingapore, SingaporeTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Singapore Health Services
- Trial code
- NCT06757296
- Record updated
- 14 February 2025
- Original description
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.Read full original descriptionShow less
Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
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.
Inclusion: 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: 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; Patients who were breast feeding or pregnant.