Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

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