Magnet Anastomosis in Patients Undergoing Gastric Surgery

Last updated: April 2, 2025
Sponsor: GI Windows, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc

Clinical Study ID

NCT06915337
GIW 25-002
  • Ages > 22
  • All Genders

Study Summary

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon SFM system plus OTOLoc when used to create a gastro-jejunal anastomosis in participants undergoing gastric surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 22 years or older at screening

  2. Candidate for gastric surgery requiring gastro-jejunal or gastro-ileal anastomosiswith 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 theduration of the study

  6. Able to refrain from smoking during study follow-up period

Exclusion

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 malrotationthat 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 becontraindicated or history of previous technically difficult or failed endoscopy

  7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree (excludinglaparoscopically removed gallbladder or prior sleeve gastrectomy), pancreas or rightcolon

  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 / PulmonaryEmbolism

  11. Immunocompromised (e.g., active treatment for malignancies, hematologic malignancy,on immunosuppressive therapy, moderate or severe primary immunodeficiency, advancedor untreated HIV, active treatment with high-dose corticosteroids (i.e., 20 or moremg of prednisone or equivalent per day when administered for 2 or more weeks priorto surgery) or other immunosuppressive or immunomodulatory agents

  12. Active H. pylori infection Participants with active H. pylori may continue with thescreening process if they are treated via medication

  13. Active or suspected infection at the surgical site or a CDC Class 3/contaminated orClass 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-upperiod

  17. Currently participating or has participated in another clinical trial within thepast 30 days and is receiving/has received an investigational drug, device, orbiologic agent

  18. Participant is not appropriate for inclusion in the clinical trial, per the medicalopinion of the Principal Investigator

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
Phase:
Study Start date:
March 29, 2025
Estimated Completion Date:
March 31, 2026

Study Description

This is a prospective, multi-center, single-arm clinical study to evaluate the GI Windows Flexagon Self Forming Magnet Anastomosis plus OTOLoc for creating gastric-jejunal anastomoses in patients undergoing gastric surgery.

Connect with a study center

  • Mohak Hitech Specialty Hospital

    Indore, Madhya Pradesh 454555
    India

    Active - Recruiting

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