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OpenTrials
Completed

NCT Number: NCT01784822

Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

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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Key information

Conditions

Ventral Hernias Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zenapro™ Hybrid Hernia Repair Device

Device

Device will be placed during open or laparoscopic hernia repair.

Primary outcomes

  1. Rate of hernia recurrence

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2013
Registry last updated
Jun 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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