Actively Recruiting
Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Led by GI Windows, Inc. · Updated on 2026-02-13
65
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than IV at time of procedure
- All cancer patients must have completed chemotherapy 2 months or more 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
You will not qualify if you...
- Known or suspected allergy to silicone, nickel, titanium or Nitinol
- Body mass index (BMI) greater than 55 kg/m2
- Uncontrolled diabetes (HbA1c greater than 10%)
- Congenital or acquired anomalies of the gastrointestinal tract that would inhibit passing of the SFM magnet
- Diagnosed with obstructed or perforated colon cancer
- Conditions contraindicating endoscopy or laparoscopy or history of difficult endoscopy that may affect magnet delivery
- Previous major surgery on the stomach, duodenum, hepatobiliary tree, pancreas, Whipple procedure, or right colon
- History of recurrent small bowel obstructions
- Coagulation deficiency not corrected by treatment or platelet count less than 50,000/µL
- Known moderate to severe renal disease (eGFR less than 44 mL/min/1.73m2) or ongoing dialysis
- Hyperkalemia, hypercoagulability, or prior venous thromboembolism or pulmonary embolism
- Immunocompromised status including active treatment for malignancies or high-dose corticosteroids use
- Congestive heart failure with ejection fraction less than 35% or clinically significant arrhythmia
- Decompensated chronic obstructive lung disease
- Active or suspected infection at the surgical site or contaminated/dirty-infected surgical wound
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning pregnancy during follow-up
- Participation in another clinical trial within past 30 days involving investigational treatments
- Participant deemed inappropriate for inclusion by the Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, Chile, 8580000
Not Yet Recruiting
2
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, India, 454555
Actively Recruiting
Research Team
P
Peter Lukin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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