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Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT01784822
First received: February 4, 2013
Last updated: June 14, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Ventral Hernias Device: Zenapro™ Hybrid Hernia Repair Device

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 Group Incorporated:

Primary Outcome Measures:
  • Rate of hernia recurrence [ Time Frame: 12 months ]

Enrollment: 63
Study Start Date: February 2013
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27704
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17036
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37902
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Cook Group Incorporated
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01784822     History of Changes
Other Study ID Numbers: 12-013
Study First Received: February 4, 2013
Last Updated: June 14, 2017

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cook Group Incorporated:
Ventral hernia
Graft repair

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

ClinicalTrials.gov processed this record on August 23, 2017