NCT01784822

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 15, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

February 4, 2013

Last Update Submit

June 14, 2017

Conditions

Ventral Hernias

Keywords

Ventral herniaGraft repair

Outcome Measures

Primary Outcomes (1)

  • Rate of hernia recurrence

    12 months

Study Arms (1)

Zenapro™ Hybrid Hernia Repair Device

Device to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias.

Device: Zenapro™ Hybrid Hernia Repair Device

Interventions

Zenapro™ Hybrid Hernia Repair DeviceDEVICE

Device will be placed during open or laparoscopic hernia repair.

Zenapro™ Hybrid Hernia Repair Device

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from University of Tennessee, Duke University and Cleveland Clinic

You may qualify if:

  • Primary or recurrent ventral hernia
  • Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Duke University

Durham, North Carolina, 27704, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17036, United States

Location

University of Tennessee

Knoxville, Tennessee, 37902, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 6, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 15, 2017

Record last verified: 2017-06

Locations

US(5)