Study of GI Windows Flexagon Self Forming Magnet Anastomosis with OTOLoc for Creating Ileo-colic and Colo-colonic Connections in Patients Undergoing Colon Surgery

What this Trial Is About

Researchers are investigating the safety and effectiveness of the Flexagon SFM system combined with the OTOLoc device for creating Ileo-colic and Colo-colonic anastomoses in patients undergoing colon surgery. This prospective, multi-center, single-arm clinical study focuses on patients requiring specific colon surgeries, such as Right Hemicolectomy or SigmoidLow Anterior resection, to better understand how these devices perform in surgical settings. The study involves delivering the Flexagon Self Forming Magnets SFMs and OTOLoc devices laparoscopically andor endoscopically into sections of the ileum or colon meant to be joined. OTOLoc devices help position and allow communication between two lumens until the anastomosis is fully formed by coupling SFMs. This procedure is evaluated for patients undergoing colon surgery, with the primary focus on successful anastomosis creation without needing reoperation within 30 days. Participants will be monitored for surgical outcomes, including the success of the anastomosis formation. Assessments will include medical clearance for surgery, post-surgical follow-up, and adherence to study requirements such as refraining from smoking. The trial tracks participants for at least 30 days after surgery to evaluate the primary outcome and ensure safety. Participation involves regular clinical visits and evaluations throughout the study period.

Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery