Obesity, MorbidGIW-J-JNCT06200896
Early Feasibility Study: Assessment of Self-Forming Magnetic Anastomosis Device and Delivery System (SFM) in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis
A study testing Self Forming Magnets used to Create A Compression Anastomosis in people with Obesity, Morbid, run by GI Windows, Inc. at 1 site in Chile.
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 with patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Self Forming Magnets used to Create A Compression Anastomosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChile
- Study dates
- 12 Dec 2023to 25 Mar 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
- Age 18-65 years at screening
- For the post sleeve gastrectomy diversion procedures (SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 40 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) ≥ 35.1 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 24 months
- 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 24 months and agree to use of contraceptives during this period and may not be nursing
Who cannot join
- Known or suspected allergy to nickel, titanium or Nitinol
- Type 1 Diabetes
- Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c >10 or use of injectable insulin
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- Contraindication to general anesthesia
- 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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- Congenital or acquired anomalies of the GI tract, including atresias, stenosis, prior obstruction or malrotation
- Presence of a duodenal diverticulum (>10mm)
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder), pancreas or right colon
- 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
- Uncontrolled severe hypertension (blood pressure >160/100mmHg)
- 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)
- Liver biochemistries (ALT and AST) ≥ 3 times the upper limit of normal
- 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
- Uncorrectable anemia (Hemoglobin < 11 g/dL in women and <12.5 g/dL in men)
- Specific genetic or hormonal cause of obesity such as Prader -Willi syndrome
- For females of child-bearing potential: Pregnancy or desire to be pregnant during the study
- Concurrent condition anticipated to require MR imaging within the first 2 months after the study procedure
- Diagnosed Bulimia Nervosa or Binge Eating Disorder (using DSM-5 criteria)
- Physical or mental disability or psychological illness that in the opinion of the Investigator would be a contraindication for bariatric surgery
- 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.
- 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"
- 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)
- Any form of substance abuse or psychiatric disorder that in the opinion of the investigator could interfere with the conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center, Two- Arm Study to Evaluate the Safety and Device Functionality of the SFM Anastomosis Device and Delivery System, When Used to Create a Duodenal-Ileal Anastomosis to Revise a Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis of a Roux-en-Y
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 with patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SFM Anastomosis System to create a Jejuno-jejunostomy in Roux-en-Y gastric bypass procedures.
Read the detailed description
This is a two-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a duodenal-ileal (D-I) anastomosis in participants who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL post sleeve gastrectomy or a patient undergoing a Roux-en-Y gastric bypass the SFM will be used to create the jejuno-jejunostomy. 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 in which the SFM device and delivery systems with create anastomoses between the duodenum and ileum or jejunum to jejunum.
- Conditions
- Obesity, Morbid
- Being tested
- Self Forming Magnets used to Create A Compression Anastomosis
- 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 Magnets used to Create A Compression AnastomosisDevice
Self Forming Magnets used to Create A Compression Anastomosis connecting the Duodenum to the ileal in Post Sleeve Gastrectomy Patients and Jejunum to jejunum in Roux-en-Y patients.
| Study group | Role | What they receive |
|---|---|---|
| SFM in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy | Experimental | Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy created with Self Forming Magnets (SFM) Receives: Device: Self Forming Magnets used to Create A Compression Anastomosis |
| SFM in Obese subjects when Used to Create a Jejuno-Jejunostomy (J-J) Anastomosis | Experimental | Jejuno-Jejunostomy (J-J) Anastomosis created with Self Forming Magnets (SFM) as part of a Roux-en-Y gastric bypass Receives: Device: Self Forming Magnets used to Create A Compression Anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability for physician to create a Magnet (SFM) Anastomosis
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: 2 days
Safety of Creating a Magnet (SFM) Anastomosis
"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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start12 Dec 2023
- Primary completion12 Jan 2025
- Study completion25 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- Juan Contreras, MD, Principal investigator, Head of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200896
- Sponsor's protocol ID
- GIW 23-004
- Acronym
- GIW-J-J
- Status last verified
- Mar 2026
- First submitted
- 29 Dec 2023
- Last updated
- 3 Apr 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Two- Arm Study to Evaluate the Safety and Device Functionality of the SFM Anastomosis Device and Delivery System, When Used to Create a Duodenal-Ileal Anastomosis to Revise a Post SG (SNAP-PS), or Used to Create a Jejuno-Jejunal (J-J) Anastomosis of a Roux-en-Y
- ClinicalTrials.gov ID
- NCT06200896
- Acronym / sponsor ID
- GIW-J-J / GIW 23-004
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GI Windows, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Jan 2025 (actual)
- Study completion
- 25 Mar 2026 (actual)
- First posted
- 11 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 with patients with prior sleeve gastrectomy who experience inadequate weight loss (i.e., SNAP-PS procedure). Additionally, the study is designed to evaluate the potential of the SFM Anastomosis System to create a Jejuno-jejunostomy in Roux-en-Y gastric bypass procedures.
Detailed description
This is a two-arm, single-center, early feasibility study to evaluate the use of the SFM Anastomosis System for creation of a duodenal-ileal (D-I) anastomosis in participants who have experienced inadequate weight loss following sleeve gastrectomy (SNAP-PS cohort) defined to be failure to achieve a minimum 50% EWL post sleeve gastrectomy or a patient undergoing a Roux-en-Y gastric bypass the SFM will be used to create the jejuno-jejunostomy. 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 in which the SFM device and delivery systems with create anastomoses between the duodenum and ileum or jejunum to jejunum.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFM in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy | Experimental | Device: Self Forming Magnets used to Create A Compression AnastomosisDuodenal-Ileal Anastomosis Post Sleeve Gastrectomy created with Self Forming Magnets (SFM) |
| SFM in Obese subjects when Used to Create a Jejuno-Jejunostomy (J-J) Anastomosis | Experimental | Device: Self Forming Magnets used to Create A Compression AnastomosisJejuno-Jejunostomy (J-J) Anastomosis created with Self Forming Magnets (SFM) as part of 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 (8 listed)
- Age 18-65 years at screening
- For the post sleeve gastrectomy diversion procedures (SNAP-PS)- Obesity with Body Mass Index (BMI) ≥ 40 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) ≥ 35.1 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 24 months
Key exclusion criteria (25 listed)
- Known or suspected allergy to nickel, titanium or Nitinol
- Type 1 Diabetes
- Uncontrolled T2DM Fasting glucose ≥ 200 mg/dl (11.1 mmol/L) and/or hemoglobin A1c >10 or use of injectable insulin
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
- 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 Magnets used to Create A Compression AnastomosisSelf Forming Magnets used to Create A Compression Anastomosis connecting the Duodenum to the ileal in Post Sleeve Gastrectomy Patients and Jejunum to jejunum in Roux-en-Y patients. | Device | SFM in Obese Patients, When Used to Create a Duodenal-Ileal Anastomosis Post Sleeve Gastrectomy, SFM in Obese subjects when Used to Create a Jejuno-Jejunostomy (J-J) Anastomosis |
Primary outcome
Ability for physician to create a Magnet (SFM) Anastomosis
Time frame: 2 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).
Safety of Creating a Magnet (SFM) Anastomosis
Time frame: 30 days
"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.
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 3 Apr 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.
Juan Contreras, MD principal investigator
Head of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self Forming Magnets used to Create A Compression Anastomosis in people with Obesity, Morbid, run by GI Windows, Inc. at 1 site in Chile.
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 8 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 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. 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?
Ability for physician to create a Magnet (SFM) Anastomosis (time frame: 2 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 3 Apr 2026.