Clinical trial Recruiting at 1 site Interventional Ages 22 and up

Using magnets to connect parts of the stomach during surgery

Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures

Run by GI Windows, Inc. · NCT06915337 · Data updated 2026-11-12

This study is testing a new way to connect parts of the stomach during surgery using magnets to see if it works safely and effectively for patients.

Quick facts

Study typeInterventional
Ages22 Years and up
SexAll
Enrollment75 (estimated)
SponsorGI Windows, Inc.
Industry-sponsored
Drugs / interventionsprednisone
Locations2 sites (Santiago, Huechuraba, Región Metropolitana and 1 other locations)
StatusRecruiting
StartedMarch 29, 2025
Main results expectedAugust 2026
Study endsDecember 2026
Registry record updatedJuly 6, 2026
Trial IDNCT06915337 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 22 and older who are scheduled for gastric surgery requiring a gastro-jejunal or gastro-ileal anastomosis.

Probably not a fit

Patients with a BMI over 55 kg/m2 or uncontrolled diabetes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the Flexagon Self Forming Magnet Anastomosis system combined with OTOLoc for creating gastro-jejunal anastomoses in patients undergoing gastric surgery. It is a prospective, multi-center, single-arm study that will assess how well this innovative approach works in facilitating the surgical connection between the stomach and the jejunum. Participants will be monitored for outcomes related to the procedure's success and any potential complications.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective gastric surgeries with improved recovery times for patients.

How similar studies have gone: While this approach is innovative, similar studies using magnet-assisted techniques have shown promise, indicating potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Aged 22 years or older at screening
2. Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosis with cardiac/medical clearance for surgery
3. Able to understand and sign informed consent document
4. American Society of Anesthesiologists (ASA) score \< IV at time of procedure
5. Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
6. Able to refrain from smoking during study follow-up period

Exclusion Criteria:

1. Known or suspected allergy to silicone, nickel, titanium or Nitinol
2. BMI \> 55 kg/m2
3. Uncontrolled diabetes (defined as HbA1c \>10%)
4. Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
5. Diagnosed with obstructed or perforated colon cancer
6. Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy
7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excluding laparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or right colon
8. Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
9. Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
10. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
11. 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
12. Active H. pylori infection Participants with active H. pylori may continue with the screening process if they are treated via medication
13. Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
14. Obstructive Sleep Apnea on CPAP unless assessed and cleared by independent physician
15. Contraindication to general anesthesia
16. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
17. Currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent
18. Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator

Where it's running

  • Mohak Hitech Specialty Hospital
    Indore, Madhya Pradesh, India
    Recruiting
  • Clinica Colonial Hospital
    Santiago, Huechuraba, Región Metropolitana, Chile
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.