Endoscopic SASI
ProcedureEndoscopic conversion to sleeve gastrectomy to SASI
NCT Number: NCT06757296
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.
Interested in participating?
Request Info21 year–65 year
All sexes
Interventional
Not applicable
Changi General Hospital, Singapore
The current standard of care for patients who experience insufficient weight loss, weight re-gain or Type II diabetes relapse after a sleeve gastrectomy is a revisional laparoscopic sleeve gastrectomy.
However, such revisional procedure is commonly associated with high mortality and morbidity due to protein malnutrition. A noval bariatric procedure, single anastomosis sleeve ileal (SASI) bypass has emerged recently.
In this study, we are utilizing an incisionless novel endoscopic technique to efficiently replicate the anatomical features and physiological effects of SASI.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subject must meet all the inclusion criteria to participate in this study and list each criterion.
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
Endoscopic conversion to sleeve gastrectomy to SASI
Time frame: 6 months
Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).
Time frame: 6 months
HbA1c levels will be measured and reported in percentage (%)
Time frame: 6 months
Quality of Life in Reflux And Dyspepsia (QoLRAD) is a questionnaire used to assess how gastroesophageal reflux disease (GERD) and dyspepsia (indigestion) affects a person's quality of life.
The total score will be calculated from the questionnaire and a reduction in QoLRAD score over time will demonstrate improvement.
Time frame: 30 days
Technical success rate & procedure related complications.
Number of adverse events will be recorded at all times to determine the feasibility and safety of the study procedure.
Contact information is provided by the study sponsor or research team.
Singapore Health Services
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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