Actively Recruiting
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
Led by GI Windows, Inc. · Updated on 2026-04-13
20
Participants Needed
1
Research Sites
17 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 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.
CONDITIONS
Official 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
- Scheduled for Right or Left Hemicolectomy, Sigmoidectomy, or Low Anterior resection with cardiac/medical clearance for surgery
- Able to understand and sign informed consent
- American Society of Anesthesiologists (ASA) score less than IV at procedure time
- Cancer patients must have completed chemotherapy at least 2 months before procedure
- Lives and plans to stay within 150 miles of study center during 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 prevent passing the SFM magnet
- Acute obstructed or perforated colon cancer at screening
- Conditions contraindicating endoscopy or laparoscopy or history of failed endoscopy
- History of recurrent small bowel obstructions
- Coagulation deficiencies 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 or pulmonary embolism
- Immunocompromised status due to various conditions or treatments
- Congestive heart failure with ejection fraction below 35% or significant arrhythmias
- Decompensated chronic obstructive lung disease
- Active or suspected infection at surgical site or contaminated/dirty-infected surgical wounds
- Contraindication to general anesthesia
- Breastfeeding, pregnant, or planning pregnancy during follow-up
- Participation in another clinical trial within past 30 days involving investigational agents
- Medical opinion that participant is inappropriate for the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orlando Health
Orlando, Florida, United States, 32806
Actively Recruiting
Research Team
P
Peter J Lukin, BS
CONTACT
J
Jessica Musiak, BS
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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