MicroCutter in Surgical Stapling - European Trial I (MET1)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study|
- Composite adverse event rate [ Time Frame: up to 30 days postoperatively ] [ Designated as safety issue: Yes ]Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection
|Study Start Date:||November 2011|
|Study Completion Date:||July 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: MicroCutter Stapling Device
Patients undergoing surgical treatment with the MicroCutter Stapling Device
Device: Microcutter XPRESS and Microcutter XCHANGE
Surgical stapling devices
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.