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The purpose of this study is to evaluate safety of the Microcutter stapling /cutting device in patients requiring the transection, resection or anastomosis of gastrointestinal tissue in a post-market approval study.
A prospective, open label, multi-center non-inferiority safety study with an all-comers enrollment of patients requiring surgical stapling of the stomach and/or intestine according to the labeled indications contained in the approved labeling. Up to 178 subjects consented for a 1-month clinical follow-up evaluation will be enrolled. Primary endpoint is to statistical non-inferiority of composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) in study patients when compared to composite major adverse event rate (composite of infection (non-dermal), dehiscence, bleeding, and strictures) as derived from a comprehensive analysis of the medical literature. The comparison will be performed for cumulative events up to 30 days postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroCutter Stapling Device | Active Comparator | Patients undergoing surgical treatment with the MicroCutter Stapling Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microcutter XPRESS and Microcutter XCHANGE | Device | Surgical stapling devices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite adverse event rate | Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection | up to 30 days postoperatively |
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Inclusion Criteria:
- All patients requiring surgical treatment where the use of a surgical stapler is anticipated
Exclusion Criteria:
- None
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Kithe, M.D. | DRK-Krankenhaus Clementinenhaud, Hannover | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DRK-Krankenahus Clementinenhaus | Hanover | Germany |
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| Label | URL |
|---|---|
| Manufacturer of MicroCutter | View source |
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