Skip to main content
OpenTrials
Completed

NCT Number: NCT01476761

MicroCutter in Surgical Stapling - European Trial I

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thoracic

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DRK-Krankenahus Clementinenhaus

Hanover, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Microcutter XPRESS and Microcutter XCHANGE

Device

Surgical stapling devices

Other names: MicroCutter XPRESS30, MicroCutter XPRESS45, MicroCutter XCHANGE30

Primary outcomes

  1. Composite adverse event rate

    Time frame: up to 30 days postoperatively

    Composite event rate is a compilation of the following stapling related adverse event rates: bleeding, leakage, stricture and infection

Sponsors and collaborators

Lead sponsor

Cardica, Inc

Industry

Registry information

Official study title

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

Acronym: MET1

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.