Evaluating the Flexagon Self Forming Magnet and OTOLoc Devices to Create Gastric-Jejunal Connections in Patients Undergoing Gastric Surgery

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Flexagon Self Forming Magnet SFM system combined with OTOLoc for creating a gastro-jejunal anastomosis in patients undergoing gastric surgery. This prospective, multi-center, single-arm clinical study focuses on patients who require gastric surgery and aims to assess clinical outcomes using this device combination. Participants undergo gastric-jejunal anastomosis where the Flexagon SFM and OTOLoc devices are placed laparoscopically or endoscopically into targeted sections of the stomach and jejunum. The OTOLoc device is first deployed into the stomach wall to allow placement of the Flexagon SFM, which is then similarly positioned in the jejunum. These magnets are coupled to form the anastomosis, allowing fluid communication until it is fully established. During the study, participants will be monitored for the success of the anastomosis creation without needing reoperation within 30 days. The study includes clinical evaluations and medical clearances before surgery, with follow-up assessments to observe outcomes and safety. Participants must remain within a certain distance from the study center and adhere to study requirements such as refraining from smoking during follow-up, with total participation lasting through the postoperative period.

Magnet Anastomosis in Patients Undergoing Gastric Surgery