Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01784822
First received: February 4, 2013
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

The Hybrid Graft study is a post-market observational study to collect data on the performance of the Hybrid Graft when used to reinforce or bridge the abdominal wall for the repair of ventral hernias.


Condition Intervention
Ventral Hernias
Device: Hybrid Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Rate of hernia recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hybrid Graft Device: Hybrid Graft
Hybrid Graft for ventral hernia repair

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients from University of Tennessee, Duke University and Cleveland Clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784822

Contacts
Contact: Brenda Johnson 765-463-7537 bmjohnson@medinst.com

Locations
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27704
Contact: Emily Thomason    919-470-7038    Emily.thomason@duke.edu   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Linda Libertini    216-445-4148    LIBERTL@ccf.org   
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17036
Contact: Lee Ann Smith    717-531-0003    Lsmith1@hmc.psu.edu   
United States, Tennessee
University of Tennessee Recruiting
Knoxville, Tennessee, United States, 37902
Contact: Susan Rawn    865-305-9227    srawn@utmck.edu   
United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Contact: Donna Neatrour    804-828-0569    dneatrour@mcvh-vcu.edu   
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01784822     History of Changes
Other Study ID Numbers: 12-013
Study First Received: February 4, 2013
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Ventral hernia
Graft repair

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 22, 2014