Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia R... | NCT01784822

Studies
Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair

NCT01784822

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Jun 15, 2017Actual

Enrollment

63Actual

Phase

Not provided

Conditions

Ventral Hernias

Interventions

Zenapro™ Hybrid Hernia Repair Device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jun 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Feb 4, 2013

First Submission Date that Met QC Criteria

Feb 5, 2013

First Posted Date

Feb 6, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2017

Last Update Posted Date

Jun 15, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Zenapro™ Hybrid Hernia Repair Device	Device	Device will be placed during open or laparoscopic hernia repair.	Zenapro™ Hybrid Hernia Repair Device

Measure	Description	Time Frame
Rate of hernia recurrence		12 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients from University of Tennessee, Duke University and Cleveland Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University		Durham	North Carolina	27704	United States
Cleveland Clinic

Condition Browse Module

MeSH Terms

ID	Term
D006555	Hernia, Ventral

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided