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Magnet Anastomosis in Patients Undergoing Gastric 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 gastro-jejunal anastomosis in participants undergoing gastric surgery.
Official title: GI Windows Flexagon Self Forming Magnet Anastomosis Plus OTOLoc for Creating Gastric-Jejunal Anastomoses in Patients Undergoing Surgical Procedures
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2025-03-29
Completion Date
2026-06
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Gastric-Jejunal Anastomosis with Flexagon SFM Device with OTOLoc
This study will investigate one type of intervention: gastric-jejunal anastomosis creation in subjects undergoing surgical procedures. Flexagon SFMs and OTOLoc devices will be delivered laparoscopically and/or endoscopically into portions of the stomach and the jejunum that are intended to be anastomosed. An OTOLoc device will be deployed into the gastric wall of the stomach to provide access for the deployment of a Flexagon SFM into the stomach. The process is repeated at an intended section of jejunum. 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