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
  Purpose

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.


Condition Intervention Phase
Thoracic
Device: Microcutter XPRESS and Microcutter XCHANGE
Phase 4

Study Type: Interventional
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

Further study details as provided by Cardica, Inc:

Primary Outcome Measures:
  • 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


Enrollment: 160
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MicroCutter Stapling Device
Patients undergoing surgical treatment with the MicroCutter Stapling Device
Device: Microcutter XPRESS and Microcutter XCHANGE
Surgical stapling devices
Other Names:
  • MicroCutter XPRESS30
  • MicroCutter XPRESS45
  • MicroCutter XCHANGE30

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476761

Locations
Germany
DRK-Krankenahus Clementinenhaus
Hannover, Germany
Sponsors and Collaborators
Cardica, Inc
Investigators
Principal Investigator: Andreas Kithe, M.D. DRK-Krankenhaus Clementinenhaud, Hannover
  More Information

Additional Information:
No publications provided

Responsible Party: Cardica, Inc
ClinicalTrials.gov Identifier: NCT01476761     History of Changes
Other Study ID Numbers: CP 2011-01
Study First Received: November 18, 2011
Last Updated: August 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Cardica, Inc:
Surgical tissue resection
Tissue dissection
Tissue transection
Anastomosis of gastrointestina tissue

ClinicalTrials.gov processed this record on April 17, 2014