The objective of this study is to confirm the safety and effectiveness of the Flexagon \& Flexagon Plus OTOLoc systems when used to create respective side-to-side anastomosis in participants undergoing laparoscopic / endoscopic small bowel surgery.
>21 years of age, at the time of informed consent
Indicated for a side-to-side duodeno-ileal diversion, jejunum-jejunum or ileal-ileal anastomosis and no other concomitant surgical procedures (i.e. hiatal hernia repair, ventral hernia repair or gallbladder removal) planned in conjunction with SFM device placement
Willing and able to comply with the Registry procedures and provide written informed consent to participate in the post market study
Participant does not provide informed consent to be enrolled and followed in the study
Participants for whom medical condition warrants use of device outside of indication for use
Breast-feeding, pregnant, or planning on becoming pregnant during the follow-up period.
Single group
Small Bowel Anastomosis
DeviceSmall Bowel Anastomosis
Number of Participants with Successful Anastomosis Creation without the Need for Reoperation
The study's primary endpoint (patient success) is defined as successful anastomosis created with the Flexagon SFM without placement procedure, device or target anastomosis-related reoperation through 30 days.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
