Safety of Flexagon SFM Plus OTOLoc for Colorectal Surgery
This study is looking at the safety and effectiveness of a new device called the Flexagon Self Forming Magnet (SFM) system plus OTOLoc. This device helps create connections (anastomoses) in the colon during surgery for conditions like colorectal cancer or diverticular diseases. The study aims to see if the Flexagon SFM plus OTOLoc can successfully create these connections without needing another surgery within 30 days. You may be able to join if you are 22 years or older, need colon surgery (like a right or left hemicolectomy, sigmoidectomy, or low anterior resection), and meet other health requirements. The study is currently unclear on its recruitment status and plans to enroll 30 participants.
- Study design
- This is an early study at a single center, involving one group of participants. It plans to enroll 30 people.
- What's involved
- You would have surgery using the study device and then have follow-up visits at discharge, 7 days, 30 days, and 60 days after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 60 days after their surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Initial Safety of SFM Plus OTOLoc for Creating Side-to-side or End-to-side Colorectal Anastomoses
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Erik Wilson, MD · STUDY_CHAIR · Chief Medical Officer
Who to contact
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What this trial measures
- Successful anastomosis created with the Flexagon SFM plus OTOLoc without reoperation.30 days
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM plus OTOLoc without placement procedure, device or target anastomosis-related reoperation through 30 days.
- Anastomosis success30 days
is defined as creation of the target anastomosis without need for conversion to open procedure due to inability to create the magnet anastomosis using laparoscopic methods, intraoperative rescue procedure such as stapled or hand-sewed rescue of failed Flexagon SFM placement (i.e. - no magnet anastomosis created in patient) or intraoperative repair of adjacent organ