Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
1 other identifier
interventional
500
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 14, 2025
December 1, 2024
1.6 years
January 19, 2024
February 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total amount of weight loss
Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).
6 months
Secondary Outcomes (2)
HbA1c
6 months
GERD symptoms
6 months
Other Outcomes (1)
Feasibility & Safety
30 days
Study Arms (1)
Intervention
EXPERIMENTALEndoscopic SASI
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singapore Health Serviceslead
- Changi General Hospitalcollaborator
- Sengkang General Hospitalcollaborator
Study Sites (3)
Changi General Hospital
Singapore, Singapore
Sengkang General Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chin Hong Lim, MD
Singapore General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
January 19, 2024
First Posted
January 3, 2025
Study Start
February 3, 2025
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 14, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share