MicroCutter in Surgical Stapling - European Trial I

Thoracic Clinical Trial

— MET1  

Official title:

The Cardica MicroCutter in Surgical Stapling: A Prospective, Open-label, Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476761
• Other study ID #: CP 2011-01
• 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

• Thoracic

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

External Links

•   Manufacturer of MicroCutter