Morbid ObesityGIW-SFMNCT06199635
Early Feasibility for Safety & Device Functionality of SFM Anastomosis Device Used in 3 Procedures (SNAP-S) or (SNAP-PS) or (J-J)
A study testing Self-Forming Magnetic Anastomosis Device and Delivery System in people with Morbid Obesity, run by GI Windows, Inc. at 2 sites in 2 countries.
Trial summary
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Self-Forming Magnetic Anastomosis Device and Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2023to 8 Jul 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Subjects:
- Age 18-65 years at screening
- For the primary or post sleeve gastrectomy Anastomosis procedures (SNAP-S/SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 but ≤ 55 kg/m2 at time of screening with or without comorbidities at time of screening. If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled
- For the Roux-en-Y gastric bypass jejuno-jejunostomy procedure (J-J) - Obesity with Body Mass Index (BMI) ≥ 35 kg/m2 but ≤50 kg/m2 with or without comorbidities at time of screening. If subject has obesity-related comorbidities such as hypertension, dyslipidemia, and sleep apnea, these comorbidities must be well-controlled.
- Able to understand and sign informed consent document
- Patient lives, and intends to remain, within a 150-km radius of study center for 12 months
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- Willing to commit to sustained healthy behaviors that include diet, eating and exercise habits for the duration of the trial
- Willing to refrain from smoking during the study follow-up period
- If subject is female, she must commit to not becoming pregnant for 12 months and agree to use of contraceptives during this period and may not be nursing
Who cannot join
- 1. Known or suspected allergy to nickel, titanium or Nitinol
- 2. Type 1 Diabetes
- 3. Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c >10 or use of injectable insulin
- 4. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- 5. Contraindication to general anesthesia
- 6. Clinically significant finding during procedural endoscopy such as presence of an unhealed ulcers, bleeding lesions, tumors or ischemic or necrotic tissue at target magnet deployment site
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- 7. Congenital or acquired anomalies of the GI tract, including atresia, stenosis, prior obstruction or malrotation
- 8. Presence of a duodenal diverticulum (>10mm)
- 9. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder), pancreas or right colon
- 10. History of chronic gastrointestinal disease (e.g., cirrhosis, inflammatory bowel disease) that in the opinion of the Investigator may preclude safe and complete study participation
- 11. Uncontrolled severe hypertension (blood pressure >160/100mmHg)
- 12. Pre-existing severe comorbid cardio-respiratory disease (e.g., congestive heart failure, uncontrolled cardiac arrhythmia, coronary artery disease, chronic obstructive lung disease requiring supplemental oxygen, pulmonary embolism, Myocardial Infarction with prior 6 months)
- 13. Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
- 14. Uncorrectable coagulation disorder (platelets < 100,000, PT >2 seconds above upper normal limit or INR >1.5) at time of procedure, Note: management of anti-platelet medications, when applicable, will follow standard practices of the institution
- 15. Uncorrectable anemia (Hemoglobin < 11 g/dL in women and <12.5 g/dL in men)
- 16. Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome
- 17. For females of child-bearing potential: Pregnancy or desire to be pregnant during the study
- 18. Concurrent condition anticipated to require MR imaging within the first 2 months after the study procedure
- 19. Diagnosed Bulimia Nervosa or Binge Eating Disorder (using DSM-5 criteria)
- 20. Physical or mental disability or psychological illness that in the opinion of the Investigator would be a contraindication for bariatric surgery
- 21. Subject is immunocompromised (e.g., active treatment for malignancies, hematologic malignancy, on immunosuppressive therapy, moderate or severe primary immunodeficiency, advanced or untreated HIV, active treatment with high-dose corticosteroids (i.e.,20 or more mg of prednisone or equivalent per day when administered for 2 or more weeks prior to surgery) or other immunosuppressive or immunomodulatory agents.
- 22. Subject has an active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound. Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator"
- 23. Other prior or concurrent conditions that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives such as the presence/diagnosis of a severe and evolutive life threatening pathology unrelated to obesity including but not limited to: ongoing infection, chronic pancreatitis, severe hepatic dysfunction, or renal dysfunction (GFR <60mL/min/1.73m2)
- 24. Any form of substance abuse or psychiatric disorder that in the opinion of the investigator could interfere with the conduct of the study
- 25. (Women only) Pregnancy at screening (+ urine hCG) or unwilling to use contraception throughout study period
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Chile1 site
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, 8580000
About this study
Official title: Evaluate the Initial Safety and Device Functionality of the SFM Anastomosis Device for a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis (SNAP-S) or After Primary Sleeve Gastrectomy (SNAP-PS) or to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass (J-J)
The objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure) or a Roux-en-Y gastric bypass jejuno-jejunostomy. Additionally, the study is designed to evaluate the potential of these procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.
Read the detailed description
This is a multi-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a Duodenal-ileal anastomosis in participants undergoing primary sleeve gastrectomy (SNAP-S cohort) or who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL at least 18 months post sleeve gastrectomy or creating the jejuno-jejunostomy anastomosis in a Roux-en-Y gastric bypass. Adult male and female subjects between the ages of 18 and 65 years-old who are candidates for the primary or revisional surgery will be considered for participation.
Patients appearing to meet basic eligibility criteria and who sign the study specific consent form will be screened for enrollment into this study and will be assessed by a multidisciplinary research team with pre-procedure nutritional and medical evaluation (including psychological and behavioral evaluation by an internist/bariatrician).
Subjects meeting the inclusion and exclusion criteria and enrolled into the study will undergo a procedure using the SFM anastomosis device in which the duodenum will be connected to the ileum with the creation of an anastomosis using the SFM device and delivery systems. For subjects undergoing concurrent sleeve gastrectomy and D-I anastomosis (SNAP-S cohort) it is anticipated that the D-I diversion will be created after the sleeve gastrectomy (unless the investigator determines that the reverse order is more appropriate for a particular subject). For subjects undergoing a Roux-en-Y gastric bypass, the standard surgical protocol will be followed at the institution coupled with the minor changes required to connect the SFM device.
- Conditions
- Morbid Obesity
- Being tested
- Self-Forming Magnetic Anastomosis Device and Delivery System
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Forming Magnetic Anastomosis Device and Delivery SystemDevice
Self-Forming Magnetic Anastomosis Device to create a gastrointestinal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| SNAP-S | Experimental | Self-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis Receives: Device: Self-Forming Magnetic Anastomosis Device and Delivery System |
| SNAP-PS | Experimental | Self-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Duodenal-ileal Anastomosis years after a Primary Sleeve Gastrectomy) Receives: Device: Self-Forming Magnetic Anastomosis Device and Delivery System |
| J-J | Experimental | Self-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass Receives: Device: Self-Forming Magnetic Anastomosis Device and Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint:
Ability to create the anastomosis with SFM without the need for open conversion or use of additional laparoscopic/endoscopic anastomoses devices (endoscopic/laparoscopic suture devices or staplers - except for closure of the laparoscopic enterotomy).
Measured: 30 days
Primary Safety Endpoint:
The primary safety endpoint for this study is "Freedom from anastomosis adverse events" or "FFAAE" within 30 days including American College of Surgeons (ACS) Grade B/C anastomosis leak (requiring active therapeutic intervention/re-laparotomy), anastomotic bleeding, and small bowel obstruction. All adverse events will be documented.
Measured: 30 days
Secondary outcomes (2)
Total Body Weight Loss (TBWL)
Percent total body weight loss (TBWL) calculated as: % TBWL = [((initial weight - final weight)) ⁄ (initial weight)] × 100
Measured: 12 months
Percent Responders
Percent of patients losing at least 10% of their baseline weight (i.e., weight at time of study procedure).
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 posted10 Jan 2024
- Study start15 Dec 2023
- Primary completion15 Jan 2025
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GI Windows, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohit Bhandari, MD, Principal investigator, Chief of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199635
- Sponsor's protocol ID
- GIW 23-005
- Acronym
- GIW-SFM
- Status last verified
- Jul 2026
- First submitted
- 28 Dec 2023
- Last updated
- 13 Jul 2026
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Initial Safety and Device Functionality of the SFM Anastomosis Device for a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis (SNAP-S) or After Primary Sleeve Gastrectomy (SNAP-PS) or to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass (J-J)
- ClinicalTrials.gov ID
- NCT06199635
- Acronym / sponsor ID
- GIW-SFM / GIW 23-005
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 10 Jan 2024 (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 objectives of this study are to assess the initial safety and device functionality of the SFM Anastomosis System including delivery systems when used to create a duodenal-ileal (D-I) anastomosis either during sleeve gastrectomy (i.e., SNAP-S procedure) or patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure) or a Roux-en-Y gastric bypass jejuno-jejunostomy. Additionally, the study is designed to evaluate the potential of these procedures to induce weight loss and to improve metabolic comorbidities in obese subjects.
Detailed description
This is a multi-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a Duodenal-ileal anastomosis in participants undergoing primary sleeve gastrectomy (SNAP-S cohort) or who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL at least 18 months post sleeve gastrectomy or creating the jejuno-jejunostomy anastomosis in a Roux-en-Y gastric bypass. Adult male and female subjects between the ages of 18 and 65 years-old who are candidates for the primary or revisional surgery will be considered for participation.
Patients appearing to meet basic eligibility criteria and who sign the study specific consent form will be screened for enrollment into this study and will be assessed by a multidisciplinary research team with pre-procedure nutritional and medical evaluation (including psychological and behavioral evaluation by an internist/bariatrician).
Subjects meeting the inclusion and exclusion criteria and enrolled into the study will undergo a procedure using the SFM anastomosis device in which the duodenum will be connected to the ileum with the creation of an anastomosis using the SFM device and delivery systems. For subjects undergoing concurrent sleeve gastrectomy and D-I anastomosis (SNAP-S cohort) it is anticipated that the D-I diversion will be created after the sleeve gastrectomy (unless the investigator determines that the reverse order is more appropriate for a particular subject). For subjects undergoing a Roux-en-Y gastric bypass, the standard surgical protocol will be followed at the institution coupled with the minor changes required to connect the SFM device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNAP-S | Experimental | Device: Self-Forming Magnetic Anastomosis Device and Delivery SystemSelf-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Primary Sleeve Gastrectomy Duodenal-Ileal Anastomosis |
| SNAP-PS | Experimental | Device: Self-Forming Magnetic Anastomosis Device and Delivery SystemSelf-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Duodenal-ileal Anastomosis years after a Primary Sleeve Gastrectomy) |
| J-J | Experimental | Device: Self-Forming Magnetic Anastomosis Device and Delivery SystemSelf-Forming Magnetic (SFM) Anastomosis Device and Delivery System being used to to Create a Jejuno-Jejunostomy in a Roux-en-Y Gastric Bypass |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All Subjects:
Key exclusion criteria (25 listed)
- 1. Known or suspected allergy to nickel, titanium or Nitinol
- 2. Type 1 Diabetes
- 3. Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c >10 or use of injectable insulin
- 4. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- 5. 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 Anastomosis Device and Delivery SystemSelf-Forming Magnetic Anastomosis Device to create a gastrointestinal anastomosis | Device | J-J, SNAP-PS, SNAP-S |
Primary outcome
Primary Effectiveness Endpoint:
Time frame: 30 days
Ability to create the anastomosis with SFM without the need for open conversion or use of additional laparoscopic/endoscopic anastomoses devices (endoscopic/laparoscopic suture devices or staplers - except for closure of the laparoscopic enterotomy).
Primary Safety Endpoint:
Time frame: 30 days
The primary safety endpoint for this study is "Freedom from anastomosis adverse events" or "FFAAE" within 30 days including American College of Surgeons (ACS) Grade B/C anastomosis leak (requiring active therapeutic intervention/re-laparotomy), anastomotic bleeding, and small bowel obstruction. All adverse events will be documented.
2 secondary outcomes
Total Body Weight Loss (TBWL)
Time frame: 12 months
Percent Responders
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 13 Jul 2026.
- 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.
Mohit Bhandari, MD principal investigator
Chief of Surgery
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Forming Magnetic Anastomosis Device and Delivery System in people with Morbid Obesity, run by GI Windows, Inc. at 2 sites in 2 countries.
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 25 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 13 Jul 2026. 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 Chile, India. 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?
Primary Effectiveness Endpoint: (time frame: 30 days). The study lists 2 primary outcomes in all. 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 13 Jul 2026.