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.
This is a prospective, multicenter, single-arm post market study of 70 minimum treated patients. Eligible patients requiring side-to-side duodeno-ileal, jejunum-jejunum \& ileal-ileal anastomosis will be evaluated for participation in the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Small 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.
Time frame: 30 Days
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