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NCT06757296Recruiting

Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.

Source: ClinicalTrials.gov · Last updated 14 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
19 Jan 2024
Start date
3 Feb 2025
Primary completion date
30 Aug 2026
Lead sponsor
Singapore Health Services
Diseases
Obesity
NCT number
NCT06757296

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 3 Feb 2025 to the primary completion date, 30 Aug 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)

Lab values

  • Treatment with anti-platelet agents that could not be temporarily discontinued

Other

  • Patients who were breast feeding or pregnant

Who the study is looking for

  • 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.

Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changi General Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
Sengkang General Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting
Singapore General Hospital
Coordinator of this site? Confirm its status
SingaporeSingaporeRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.