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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01476761
Other study ID # CP 2011-01
Secondary ID
Status Completed
Phase Phase 4
First received November 18, 2011
Last updated August 7, 2013
Start date November 2011
Est. completion date July 2013

Study information

Verified date August 2013
Source Cardica, Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date July 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Microcutter XPRESS and Microcutter XCHANGE
Surgical stapling devices

Locations

Country Name City State
Germany DRK-Krankenahus Clementinenhaus Hannover

Sponsors (1)

Lead Sponsor Collaborator
Cardica, Inc

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite adverse event rate Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection up to 30 days postoperatively Yes
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