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

Last updated: February 13, 2025
Sponsor: Singapore Health Services
Overall Status: Active - Recruiting

Phase

N/A

Condition

Metabolic Syndrome

Weight Loss

Gastroesophageal Reflux Disease (Gerd)

Treatment

Endoscopic SASI

Clinical Study ID

NCT06757296
2024-3067
  • Ages 21-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subject must meet all the inclusion criteria to participate in this study and list each criterion.

  1. Age: 21-65 years

  2. Patients going for LSG at participating hospitals.

  3. 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

Exclusion Criteria:

  1. Patients who were breast feeding or pregnant

  2. Severe psychiatric illness

  3. Eating disorder

  4. Active neoplastic disease

  5. End-stage renal disease

  6. Patients with bleeding diathesis

  7. Patients with pacemakers or implantable cardiac defibrillators

  8. Significant cardiovascular disease (e.g., acute myocardial infarction, congestivecardiac failure, ischemic heart disease, atrial fibrillation, sick sinus syndrome,supraventricular tachycardia)

  9. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol orsubstance abuse; history of unreliability in medication taking or appointmentkeeping; significant concerns about participation in the study from spouse,significant other or family members)

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

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Endoscopic SASI
Phase:
Study Start date:
February 03, 2025
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Changi General Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • Sengkang General Hospital

    Singapore,
    Singapore

    Active - Recruiting

  • Singapore General Hospital

    Singapore,
    Singapore

    Active - Recruiting

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