Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Ventral Hernias Clinical Trial

Official title:

Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784822
• Other study ID #: 12-013
• Status: Completed
• Phase: N/A
• First received: February 4, 2013
• Last updated: June 14, 2017
• Start date: February 2013
• Est. completion date: June 2016

Study information

• Verified date: June 2017
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernias

Intervention

Device:
• Zenapro™ Hybrid Hernia Repair Device
Device will be placed during open or laparoscopic hernia repair.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Tennessee	Knoxville	Tennessee
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of hernia recurrence		12 months