Metabolic SyndromeNCT06757296
Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
A study testing Endoscopic SASI in people with Metabolic Syndrome and Severe Obesity, run by Singapore Health Services at 3 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Metabolic Syndrome, Severe Obesity, Reflux, Gastroesophageal
- What is being tested?
- Endoscopic SASI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesSingapore
- Study dates
- 3 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who were breast feeding or pregnant
- Severe psychiatric illness
- Eating disorder
- Active neoplastic disease
- End-stage renal disease
- Patients with bleeding diathesis
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wei Min Chong, MSc contact
Singapore3 sites, 3 recruiting
- Recruiting
Changi General Hospital
Singapore
Jinlin Lin, MD, +6567888833, lin.jinlin@singhealth.com.sg
Jinlin Lin, MD
- Recruiting
Sengkang General Hospital
Singapore
Baldwin Po Man Yeung, MD, +6569305000, baldwin.yeung.p.m@singhealth.com.sg
Baldwin Po Man Yeung, MD
- Recruiting
Singapore General Hospital
Singapore
Chin Hong Lim, MD, +65 62223322, lim.chin.hong@singhealth.com.sg
Wei Min Chong, MSc
About this study
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.
Read the detailed 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.
- Being tested
- Endoscopic SASI
- Keywords
- SASI, Severe Obesity, Bariatric Surgery
- Medical subject headings
- Metabolic Syndrome, Obesity, Morbid, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic SASIProcedure or surgery
Endoscopic conversion to sleeve gastrectomy to SASI
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Endoscopic SASI Receives: Procedure: Endoscopic SASI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 6 months
Secondary outcomes (2)
HbA1c
HbA1c levels will be measured and reported in percentage (%)
Measured: 6 months
GERD symptoms
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start3 Feb 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- Changi General Hospital, Sengkang General Hospital
- Responsible party
- Principal investigator, Chin Hong Lim, Singapore Health Services
- Investigators
- Chin Hong Lim, MD, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757296
- Sponsor's protocol ID
- 2024-3067
- Status last verified
- Dec 2024
- First submitted
- 19 Jan 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Conversion of Sleeve Gastrectomy to Single Anastomosis Sleeve-ileal Bypass (SASI) for Gastroesophageal Reflux (GERD), Primary and Secondary Non-responder.
- ClinicalTrials.gov ID
- NCT06757296
- Acronym / sponsor ID
- 2024-3067
- Keywords
- SASI, Severe Obesity, Bariatric Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Singapore Health ServicesUniversity, hospital or other
- Collaborators
- Changi General Hospital, Sengkang General Hospital
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Endoscopic SASIEndoscopic SASI |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients who were breast feeding or pregnant
- Severe psychiatric illness
- Eating disorder
- Active neoplastic disease
- End-stage renal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic SASIEndoscopic conversion to sleeve gastrectomy to SASI | Procedure or surgery | Intervention |
Primary outcome
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 (%).
2 secondary outcomes
HbA1c
Time frame: 6 months
GERD symptoms
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Min Chong, MSc contact
Chin Hong Lim, MD principal investigator
Singapore General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic SASI in people with Metabolic Syndrome and Severe Obesity, run by Singapore Health Services at 3 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chin Hong Lim, MD (62223322, lim.chin.hong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of weight loss (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.