NCT01476761

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

1.6 years

First QC Date

November 18, 2011

Last Update Submit

August 7, 2013

Conditions

Thoracic

Keywords

Surgical tissue resectionTissue dissectionTissue transectionAnastomosis of gastrointestina tissue

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MicroCutter Stapling Device

ACTIVE COMPARATOR

Patients undergoing surgical treatment with the MicroCutter Stapling Device

Device: Microcutter XPRESS and Microcutter XCHANGE

Interventions

Microcutter XPRESS and Microcutter XCHANGEDEVICE

Surgical stapling devices

Also known as: MicroCutter XPRESS30, MicroCutter XPRESS45, MicroCutter XCHANGE30
MicroCutter Stapling Device

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DRK-Krankenahus Clementinenhaus

Hanover, Germany

Location

Related Links

Study Officials

  • Andreas Kithe, M.D.

    DRK-Krankenhaus Clementinenhaud, Hannover

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 22, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

July 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

DE(1)