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Flexagon Plus OTOLoc Colon Anastomosis in Patients Undergoing Surgery
Sponsor: GI Windows, Inc.
Summary
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.
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Ileo-colic and Colo-colonic Anastomoses in Patients Undergoing Surgical Procedures
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2025-03-29
Completion Date
2026-07
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Ileo-colic and colo-colonic Anastomosis with Flexagon SFM and OTOLoc
This study will investigate two types of intervention: ileo-colic and colo-colonic anastomosis creation in subjects undergoing colon surgery. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into a portion of either the ileum or the colon that are intended to be anastomosed. An OTOLoc device will be deployed into the ileum/colon wall to provide access for the deployment of a Flexagon SFM into the bowel. The process is repeated at an intended section of colon. Once deployed, the Flexagon SFMs are approximated and positioned, after which the SFMs are couple together to form the anastomosis, with the OTOLoc devices allowing fluidic communication between the two lumens until the anastomosis is fully formed.
Locations (2)
Clinica Colonial Hospital
Santiago, Huechuraba, Región Metropolitana, Chile
Mohak Hitech Specialty Hospital
Indore, Madhya Pradesh, India