Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

C

Cook Group

Status

Completed

Conditions

Ventral Hernias

Treatments

Device: Zenapro™ Hybrid Hernia Repair Device

Study type

Observational

Funder types

Industry

Identifiers

NCT01784822
12-013

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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

Trial design

63 participants in 1 patient group

Zenapro™ Hybrid Hernia Repair Device
Description:
Device to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias.
Treatment:
Device: Zenapro™ Hybrid Hernia Repair Device

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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