Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Ventral Hernias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Zenapro™ Hybrid Hernia Repair Device

Device to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias.

Zenapro™ Hybrid Hernia Repair Device

Intervention Type DEVICE

Device will be placed during open or laparoscopic hernia repair.

Interventions

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Zenapro™ Hybrid Hernia Repair Device

Device will be placed during open or laparoscopic hernia repair.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No