Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

June 14, 2017 updated by: Cook Group Incorporated
The objective this study is to collect post-market data on the performance of the Zenapro™ Hybrid Hernia Repair Device when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17036
        • Penn State Milton S. Hershey Medical Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37902
        • University of Tennessee
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from University of Tennessee, Duke University and Cleveland Clinic

Description

Inclusion Criteria:

  • Primary or recurrent ventral hernia
  • Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result

Exclusion Criteria:

  • Age < 21 (i.e., infants, children)
  • Device intended to be used in an infected wound
  • Known sensitivity to porcine material
  • Pregnant or planning pregnancy in the future
  • Life expectancy of less than 12 months from the date of the index procedure
  • Hernia too large to be covered with a single device with at least 4-5 cm of tissue overlap on all sides

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Zenapro™ Hybrid Hernia Repair Device
Device to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias.
Device: Zenapro™ Hybrid Hernia Repair Device
Device will be placed during open or laparoscopic hernia repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of hernia recurrence
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Group Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Actual)

June 15, 2017

Last Update Submitted That Met QC Criteria

June 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-013 (Research Ethics Board,JGH)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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