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MicroCutter in Surgical Stapling - European Trial I (MET1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cardica, Inc
ClinicalTrials.gov Identifier:
NCT01476761
First received: November 18, 2011
Last updated: August 7, 2013
Last verified: August 2013

November 18, 2011
August 7, 2013
November 2011
June 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01476761 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
MicroCutter in Surgical Stapling - European Trial I
The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study

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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thoracic
Device: Microcutter XPRESS and Microcutter XCHANGE
Surgical stapling devices
Other Names:
  • MicroCutter XPRESS30
  • MicroCutter XPRESS45
  • MicroCutter XCHANGE30
Active Comparator: MicroCutter Stapling Device
Patients undergoing surgical treatment with the MicroCutter Stapling Device
Intervention: Device: Microcutter XPRESS and Microcutter XCHANGE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
July 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

- All patients requiring surgical treatment where the use of a surgical stapler is anticipated

Exclusion Criteria:

- None

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01476761
CP 2011-01
Yes
Cardica, Inc
Cardica, Inc
Not Provided
Principal Investigator: Andreas Kithe, M.D. DRK-Krankenhaus Clementinenhaud, Hannover
Cardica, Inc
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP