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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duodeno-ileal diversion anastomosis | Other | Small Bowel Anastomosis with Flexagon SFM Device |
|
| Jejunum-jejunum & ileal-ileal anastomosos | Other | Small Bowel Anastomosis with Flexagon SFM Device with OTOLoc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small Bowel Anastomosis | Device | Small Bowel Anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pete Lukin | Contact | 978 761 0183 | peter.lukin@giwindows.com |
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