Ventral HerniasNCT01784822
Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
An observational study of Ventral Hernias, run by Cook Group Incorporated at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ventral Hernias
- What is being tested?
- Zenapro™ Hybrid Hernia Repair Device
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from University of Tennessee, Duke University and Cleveland Clinic
Who may be able to join
- Primary or recurrent ventral hernia
- Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27704
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17036
University of Tennessee
Knoxville, Tennessee, 37902
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
- Conditions
- Ventral Hernias
- Being tested
- Zenapro™ Hybrid Hernia Repair Device
- Keywords
- Ventral hernia, Graft repair
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenapro™ Hybrid Hernia Repair DeviceDevice
Device will be placed during open or laparoscopic hernia repair.
| Study group | Role | What they receive |
|---|---|---|
| Zenapro™ Hybrid Hernia Repair Device | Device to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias. Receives: Device: Zenapro™ Hybrid Hernia Repair Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hernia recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01784822
- Sponsor's protocol ID
- 12-013
- Status last verified
- Jun 2017
- First submitted
- 4 Feb 2013
- Last updated
- 15 Jun 2017
- Results posted
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zenapro™ Hybrid Hernia Repair Device for Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01784822
- Acronym / sponsor ID
- 12-013
- Conditions
- Ventral Hernias
- Keywords
- Ventral hernia, Graft repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zenapro™ Hybrid Hernia Repair Device | – | Device: Zenapro™ Hybrid Hernia Repair DeviceDevice to be used to reinforce or bridge the abdominal wall for the repair of ventral hernias. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from University of Tennessee, Duke University and Cleveland Clinic
Key inclusion criteria (2 listed)
- Primary or recurrent ventral hernia
- Need for abdominal wall repair with reinforcement or bridging material to obtain the desired surgical result
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zenapro™ Hybrid Hernia Repair DeviceDevice will be placed during open or laparoscopic hernia repair. | Device | Zenapro™ Hybrid Hernia Repair Device |
Primary outcome
Rate of hernia recurrence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernias, run by Cook Group Incorporated at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of hernia recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2017.