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NCT Number: NCT06757296

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.

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Key information

About this study

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.

Who can participate

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.

  • 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 criteria

  • 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

Treatment and study plan

Endoscopic SASI

Procedure

Endoscopic conversion to sleeve gastrectomy to SASI

Primary outcomes

  1. Total amount of weight loss

    Time frame: 6 months

    Amount of weight loss after endoscopic conversion to SASI will be measured in kg and will be reported in percentage (%).

Secondary outcomes

  1. HbA1c

    Time frame: 6 months

    HbA1c levels will be measured and reported in percentage (%)

  2. GERD symptoms

    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.

Other outcomes

  1. Feasibility & Safety

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chin Hong Lim, MD

CONTACT

[email protected]

62223322

Wei Min Chong, MSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Singapore Health Services

Other

Collaborators

  • Changi General Hospital
  • Sengkang General Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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