MicroCutter in Surgical Stapling - European Trial I (MET1)

This study is currently recruiting participants.

Verified November 2011 by Cardica, Inc

Sponsor:

Information provided by (Responsible Party):

Cardica, Inc

ClinicalTrials.gov Identifier:

NCT01476761

First received: November 18, 2011

Last updated: November 29, 2011

Last verified: November 2011

History of Changes

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

Estimated Enrollment:	178
Study Start Date:	November 2011
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	January 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

Contacts

Contact: Andreas Kuthe, MD

+49 511 3394-0

Locations

Germany
DRK-Krankenahus Clementinenhaus	Recruiting
Hannover, Germany
Contact: Andreas Kuthe, Dr. med.

Sponsors and Collaborators

Cardica, Inc

Investigators

Principal Investigator:

Andreas Kithe, M.D.

DRK-Krankenhaus Clementinenhaud, Hannover

More Information

Additional Information:

Manufacturer of MicroCutter This link exits the ClinicalTrials.gov site

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:	November 29, 2011
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 May 19, 2013

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