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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014