Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01784822

Enrollment

Registered

2013-02-06

Start date

2013-02-28

Completion date

2016-06-30

Last updated

2017-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventral Hernias

Keywords

Ventral hernia, Graft repair

Brief 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.

Interventions

DEVICEZenapro™ Hybrid Hernia Repair Device

Device will be placed during open or laparoscopic hernia repair.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Rate of hernia recurrence	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026