Actively Recruiting
Safety and Device Functionality of the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic, Colo-colonic and Colorectal Anastomoses in Patients Undergoing Surgical Procedures
Led by GI Windows, Inc. · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Flexagon 25mm Self Forming Magnet (SFM) system plus OTOLoc device in creating side-to-side Ileo-colic, Colo-colonic, and side-to-side or end-to-side colorectal anastomoses in patients undergoing colon surgery. This prospective, single-center, single-arm early feasibility study aims to assess if the device can successfully create the target anastomosis without the need for reoperation related to the placement procedure, device, or anastomosis within 30 days. The study includes a roll-in training cohort and a primary analysis cohort to gather comprehensive safety data.
CONDITIONS
Brief Title
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 22 years or older at screening
- Candidate for surgery requiring Right or Left Hemicolectomy, 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 less than IV at time of procedure
- All cancer patients must have completed chemotherapy at least 2 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 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 with HbA1c greater than 10%
- Congenital or acquired gastrointestinal tract anomalies that would prevent passing of the SFM magnet
- Acute diagnosis of obstructed or perforated colon cancer at screening
- Conditions contraindicating endoscopy or laparoscopy or history of failed endoscopy suggesting difficulty with magnet delivery
- History of recurrent small bowel obstructions
- Coagulation deficiency not corrected by treatment or platelet count below 50,000/µL
- Moderate to severe renal disease or ongoing dialysis
- Hyperkalemia, hypercoagulability, or prior venous thromboembolism/pulmonary embolism
- Immunocompromised status including active malignancy treatment or advanced HIV
- Congestive heart failure with ejection fraction less than 35% or significant arrhythmia except specified rhythms
- Decompensated chronic obstructive lung disease
- Active or suspected infection at surgical site or contaminated surgical wound
- Contraindication to general anesthesia
- Breast-feeding, pregnant, or planning pregnancy during follow-up
- Participation in another clinical trial within past 30 days with investigational treatments
- Considered inappropriate for trial inclusion by Principal Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo laparoscopic colon surgery using the Flexagon Self Forming Magnet Anastomosis Plus OTOLoc device to create side-to-side or end-to-side colorectal anastomoses under general anesthesia.
1 surgical procedure visit (in-person)
Duration - Up to 60 days after surgery
Participants are monitored clinically after surgery to assess recovery and device safety at discharge and during follow-up visits.
4 visits (at discharge, Day 7, Day 30, and Day 60)
Trial Site Locations
Total: 1 location
1
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
Research Team
P
Peter J Lukin, BS
J
Jessica Musiak, BS
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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