Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery

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

Phase

N/A

Condition

N/A

Treatment

Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc

Clinical Study ID

NCT06915818
GIW 25-003
  • 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 22 years or older at screening

  2. Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anteriorresection (with anastomosis above the peritoneal reflection) with cardiac/medicalclearance for surgery

  3. Able to understand and sign informed consent document

  4. American Society of Anesthesiologists (ASA) score < IV at time of procedure

  5. All cancer patients must have completed chemotherapy ≥2 months prior to procedure

  6. Lives, and intends to remain, within a 300 kilometers radius of study center for theduration of the study

  7. 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 endoscopythat may suggest difficulty during endoscopic delivery of magnets

  7. Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas,Whipple or right colon

  8. History of recurrent small bowel obstructions.

  9. Coagulation deficiency not normalized by medical treatment or platelet count <50,000/µL

  10. Known moderate to severe renal disease (eGFR < 44 milliliters per minute per 1.73m2)or ongoing dialysis

  11. Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / PulmonaryEmbolism

  12. 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

  13. Congestive heart failure with ejection fraction <35% or clinically significantarrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or asinus rhythm with premature atrial or ventricular complexes)

  14. Decompensated chronic obstructive lung disease

  15. Active or suspected infection at the surgical site or a CDC Class 3/contaminated orClass 4/dirty-infected surgical wound.

  16. Contraindication to general anesthesia

  17. Breast-feeding, pregnant, or planning on becoming pregnant during the follow-upperiod

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

  19. Contraindication to general anesthesia

  20. 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: Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and 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 Ileo-colic and Colo-colonic anastomoses in participants undergoing colon surgery.

Connect with a study center

  • Mohak Hitech Specialty Hospital

    Indore, Madhya Pradesh 454555
    India

    Active - Recruiting

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