ObesityNCT04627103
Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
A study testing Self Forming Magnetic (SFM) Anastomosis System in people with Obesity and Type 2 Diabetes Mellitus, run by GI Windows, Inc. at 2 sites in Canada.
Trial summary
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Self Forming Magnetic (SFM) Anastomosis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesCanada
- Study dates
- 7 Oct 2021to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-65 years at screening
- Body mass index (BMI) ≥35 and ≤50
- T2DM diagnosis ≥6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but < 10.0% at time of enrollment.
- HbA1c must be stable over a 3-month period.
- Weight stable over 3-month period
- Obesity-related comorbidities (hypertension, dyslipidemia, sleep apnea) must be well-controlled
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- Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
- If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
- Able to understand and sign informed consent documents.
Who cannot join
- Known or suspected allergy to nickel or titanium or nitinol
- Type 1 diabetes or poorly controlled type 2 diabetes
- Use of injectable insulin
- Any documented conditions for which endoscopy would be contraindicated
- Contraindication to general anesthesia
- History of chronic gastrointestinal disease
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- Congenial or acquired anomalies of the GI tract
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
- Uncontrolled hypertension
- Pre-existing severe comorbid cardio-respiratory disease
- History of chronic gastrointestinal disease
- Specific genetic or hormonal cause of obesity
- Recent tobacco/nicotine product cessation (within 3 months prior)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9
Université Laval
Québec, Quebec, G1V 4G5
About this study
Official title: A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
Read the detailed description
Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Self Forming Magnetic (SFM) Anastomosis System
- Keywords
- Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Disease, Sleeve Gastrectomy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self Forming Magnetic (SFM) Anastomosis SystemDevice
The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.
| Study group | Role | What they receive |
|---|---|---|
| Device Placement | Experimental | The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed. Receives: Device: Self Forming Magnetic (SFM) Anastomosis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Weight loss measured as a percent of total body weight (TBW)
Measured: 12 months
Secondary outcomes (13)
Percent Responders
Percent responders; i.e. percent of subjects losing at least 10% TBW
Measured: 12 months
Excess Weight Loss Measures
Excess weight loss (EWL)
Measured: 12 months
Absolute Weight Loss Measures
Absolute weight loss
Measured: 12 months
BMI - Weight Loss Measures
Change in BMI
Measured: 12 months
Fasting Glucose
Mean change in fasting glucose
Measured: 12 months
Hemoglobin A1c
Mean change in Hemoglobin A1c
Measured: 12 months
Diabetes Remission and/or Improvements
Proportion of subjects experiencing diabetes remission and/or improvements
Measured: 12 months
Diabetes Medication Dosage and Frequency Changes
Mean change in the dosage and frequency of diabetes medications from baseline
Measured: 12 months
Serum Lipids
Mean change in serum lipids
Measured: 12 months
Blood Pressure Changes
Mean percent change in systolic/diastolic blood pressure
Measured: 12 months
Liver Changes using Fibroscan
Change in Controlled Attenuation Parameter (CAP) Scores from baseline
Measured: 12 months
Nutritional Status
Nutritional Status: changes in pre-albumin levels
Measured: 12 months
Albumin - Nutritional Status
Nutritional Status: changes in albumin levels
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start7 Oct 2021
- Primary completion30 Jul 2024
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627103
- Sponsor's protocol ID
- GIW 20-001
- Status last verified
- Nov 2025
- First submitted
- 2 Nov 2020
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial for a Procedure for Duodenal-Ileal Diversion With a Sleeve Gastrectomy for Patients With Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04627103
- Acronym / sponsor ID
- GIW 20-001
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Obesity, Diabetes Mellitus, Diabetes Mellitus, Type 2, Metabolic Disease, Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 13 Nov 2020 (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.
Study will monitor weight loss and metabolic indicators for subjects in multi-center, single arm trial.
Detailed description
Multi-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion with a Sleeve Gastrectomy (SNAP-S) for Subjects with Obesity and Type 2 Diabetes Mellitus (T2DM)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Placement | Experimental | Device: Self Forming Magnetic (SFM) Anastomosis SystemThe subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion. Following the diversion creation, a sleeve gastrectomy will also be performed. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 19-65 years at screening
- Body mass index (BMI) ≥35 and ≤50
- T2DM diagnosis ≥6 months but < 10 years, with 1 or more oral diabetes medications, HbA1c ≥ 6.5% but < 10.0% at time of enrollment.
- HbA1c must be stable over a 3-month period.
- Weight stable over 3-month period
Key exclusion criteria (13 listed)
- Known or suspected allergy to nickel or titanium or nitinol
- Type 1 diabetes or poorly controlled type 2 diabetes
- Use of injectable insulin
- Any documented conditions for which endoscopy would be contraindicated
- Contraindication to general anesthesia
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 |
|---|---|---|
| Self Forming Magnetic (SFM) Anastomosis SystemThe SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique. | Device | Device Placement |
Primary outcome
Weight Loss
Time frame: 12 months
Weight loss measured as a percent of total body weight (TBW)
13 secondary outcomes
Percent Responders
Time frame: 12 months
Excess Weight Loss Measures
Time frame: 12 months
Absolute Weight Loss Measures
Time frame: 12 months
BMI - Weight Loss Measures
Time frame: 12 months
Fasting Glucose
Time frame: 12 months
Hemoglobin A1c
Time frame: 12 months
Diabetes Remission and/or Improvements
Time frame: 12 months
Diabetes Medication Dosage and Frequency Changes
Time frame: 12 months
Serum Lipids
Time frame: 12 months
Blood Pressure Changes
Time frame: 12 months
Liver Changes using Fibroscan
Time frame: 12 months
Nutritional Status
Time frame: 12 months
Albumin - Nutritional Status
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Forming Magnetic (SFM) Anastomosis System in people with Obesity and Type 2 Diabetes Mellitus, run by GI Windows, Inc. at 2 sites in Canada.
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 9 inclusion and 13 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: 12 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 20 Nov 2025.