Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses

Recruiting now · Not applicable

Conditions studied: Colorectal Cancer, Diverticular Diseases

In brief

The primary objective of this trial is to investigate the safety and effectiveness of the Flexagon 25mm SFM system plus OTOLoc when used to create a side-to-side Ileo-colic, Colo-colonic and side-to-side or end-to-side colorectal anastomoses in participants undergoing colon surgery. This will be evaluated via a composite safety/effectiveness endpoint of patient success defined as successful creation of the target anastomosis without placement procedure, device or target anastomosis related reoperation through 30 days.

Key facts

Study ID: NCT07276529
Run by: GI Windows, Inc.
People needed: 30
Starts: 2026-04-01
Expected to finish: 2026-12-01
Last updated by the study team: 2026-07-06

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Aged 22 years or older at screening
Candidate for surgery requiring Right of Left Hemicolectomy or Sigmoidectomy or Low Anterior resection 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 ≥1 months prior to procedure
Lives, and intends to remain, within a 150-mile radius of study center for the duration of the study
Able to refrain from smoking during study follow-up period

You may not qualify if…

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
Participants with an acute diagnosis of obstructed or perforated colon cancer at the time of the Screening Visit
Any documented conditions for which endoscopy and/or laparoscopy would be contraindicated or history of previous failed endoscopy that may suggest difficulty during endoscopic delivery of magnets
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

Where it is running

Orlando Health — Orlando, Florida, United States (enrolling)
University of Texas Health Science Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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