CClinicalTrials.gg
CompletedNCT01784822Updated Jun 15, 2017

Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

An observational study in Ventral Hernias, sponsored by Cook Group Incorporated. Completed at 5 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-06-15.

Sponsored by Cook Group Incorporated · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
63
Ages
21 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Ventral Hernias

Keywords

  • Ventral hernia
  • Graft repair
03

In context

Hernia

1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.

This study's enrollment of 63 is below the median of 120 across 327 observational studies indexed under Hernia.

Browse Hernia studies →

Lead sponsor

Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from University of Tennessee, Duke University and Cleveland Clinic

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
63 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DeviceZenapro™ Hybrid Hernia Repair Device

    Device will be placed during open or laparoscopic hernia repair.

06

What researchers measure

Primary outcomes

  1. Rate of hernia recurrence

    Time frame: 12 months

07

Study locations

5 sites
  • Duke University
    Durham, North Carolina 27704, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17036, United States
  • University of Tennessee
    Knoxville, Tennessee 37902, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01784822
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
Feb 6, 2013
Start date
Feb 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jun 15, 2017

Oversight

FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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