Functional Lumen Opening With Self-Forming Magnetic Anastomosis

Last updated: April 2, 2025
Sponsor: GI Windows, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc

Clinical Study ID

NCT06454916
GIW 24-001
  • 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 small bowel anastomosis in subjects undergoing laparoscopic small bowel surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 22 years or older at screening

  2. Candidate for laparoscopic small bowel surgery requiring small bowel 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 185-mile 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 malrotation

  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

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

Study Design

Total Participants: 70
Treatment Group(s): 1
Primary Treatment: Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc
Phase:
Study Start date:
October 04, 2024
Estimated Completion Date:
August 31, 2025

Study Description

This is a multicenter, pivotal study in which clinical outcomes will be prospectively evaluated for a minimum of 70 subjects undergoing anastomosis creation using the Flexagon SFM system plus OTOLoc.

Connect with a study center

  • Fresno Community Hospital and Medical Center

    Clovis, California 93611
    United States

    Site Not Available

  • University of Miami

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

  • Endeavor Health

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Duke Regional Hospital

    Durham, North Carolina 27704
    United States

    Site Not Available

  • UT Health Houston

    Houston, Texas 77401
    United States

    Site Not Available

  • Seger Bariatrics and Metabolism, LLC

    San Antonio, Texas 78229
    United States

    Site Not Available

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