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MicroCutter in Surgical Stapling - European Trial I

NCT ID: NCT01476761

Last Updated: 2013-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thoracic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MicroCutter Stapling Device

Patients undergoing surgical treatment with the MicroCutter Stapling Device

Group Type ACTIVE_COMPARATOR

Microcutter XPRESS and Microcutter XCHANGE

Intervention Type DEVICE

Surgical stapling devices

Interventions

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Microcutter XPRESS and Microcutter XCHANGE

Surgical stapling devices

Intervention Type DEVICE

Other Intervention Names

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MicroCutter XPRESS30 MicroCutter XPRESS45 MicroCutter XCHANGE30

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardica, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Kithe, M.D.

Role: PRINCIPAL_INVESTIGATOR

DRK-Krankenhaus Clementinenhaud, Hannover

Locations

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DRK-Krankenahus Clementinenhaus

Hanover, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.cardica.com

Manufacturer of MicroCutter

Other Identifiers

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CP 2011-01

Identifier Type: -

Identifier Source: org_study_id

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