Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
Recruiting · NCT07276529 · Interventional (participants receive a specific treatment) · Lead sponsor: GI Windows, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating side-to-side Colon Anatomoses
What this trial is about
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.
Who can take part
Age range
22 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
2 locations listed across 2 US states.
- Orlando Health - Orlando, Florida, United States
- University of Texas Health Science Center - Houston, Texas, United States