Status:
RECRUITING
Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Lead Sponsor:
GI Windows, Inc.
Conditions:
Colon Anastomosis
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 ...
Detailed 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 p...
Eligibility Criteria
Inclusion
- Aged 22 years or older at screening
- Candidate for surgery requiring Right Hemicolectomy or Sigmoid / Low Anterior resection (with anastomosis above the peritoneal reflection) with cardiac/medical clearance for surgery
- Able to understand and sign informed consent document
- American Society of Anesthesiologists (ASA) score \< IV at time of procedure
- All cancer patients must have completed chemotherapy ≥2 months prior to procedure
- Lives, and intends to remain, within a 300 kilometers radius of study center for the duration of the study
- Able to refrain from smoking during study follow-up period
Exclusion
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- BMI \> 55 kg/m2
- Uncontrolled diabetes (defined as HbA1c \>10%)
- Congenital or acquired anomalies of the GI tract, including atresia or malrotation that would inhibit passing of SFM magnet
- Diagnosed with obstructed or perforated colon cancer
- Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous technically difficult or failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
- Any previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple or right colon
- History of recurrent small bowel obstructions.
- Coagulation deficiency not normalized by medical treatment or platelet count \<50,000/µL
- Known moderate to severe renal disease (eGFR \< 44 milliliters per minute per 1.73m2) or ongoing dialysis
- Hyperkalemia / hypercoagulability or prior Venus Thromboembolism / Pulmonary Embolism
- 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
- Congestive heart failure with ejection fraction \<35% or clinically significant arrhythmia (any rhythm disturbances except sinus tachycardia, sinus bradycardia or a sinus rhythm with premature atrial or ventricular complexes)
- Decompensated chronic obstructive lung disease
- Active or suspected infection at the surgical site or a CDC Class 3/contaminated or Class 4/dirty-infected surgical wound.
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period
- 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
- Contraindication to general anesthesia
- Participant is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator
Key Trial Info
Start Date :
March 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06915818
Start Date
March 29 2025
End Date
March 1 2026
Last Update
November 13 2025
Active Locations (2)
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1
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, Chile, 8580000
2
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, India, 454555