Ventral HerniaNCT04294446
Post-market Study of the Biodesign Hernia Graft
An observational study of Ventral Hernia, run by Cook Biotech Incorporated at 3 sites in 2 countries.
Trial summary
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Biodesign Hernia Graft
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Nov 2020to 26 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.
Who may be able to join
- 1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft
Who cannot join
- Known sensitivity to porcine material
- For the study, the following patients will also be excluded:
- Age < 18 years
- Unable or unwilling to provide informed consent
- Life expectancy of less than one year from the date of the index procedure
- Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their index procedure.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Queen Elizabeth II Hospital
Halifax, Nova Scotia, B3H 2Y9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Post-market Study of the Biodesign® Hernia Graft
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
Read the detailed description
This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair.
This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site.
This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.
- Conditions
- Ventral Hernia
- Being tested
- Biodesign Hernia Graft
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodesign Hernia GraftDevice
The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia Recurrence
Hernia recurrence through 1-year follow-up
Measured: 1-year
Secondary outcomes (8)
Device-, Procedure-, and Hernia-related Adverse Event Rates
Summarize the adverse event rates for normal commercial use of the device (e.g., seroma and infection rates)
Measured: 2-year
Hernia Recurrence Rate Through 2-year Follow-up
Assess the long-term success of the device in the reinforcement of hernia repairs through 2-year follow-up
Measured: 2-year
Operative Times
What was the operation time for the ventral hernia repair for patients who had a follow-up at least 1 month after procedure.
Measured: During operation
Hospital Stays for Serious Adverse Events
Number of patients with serious adverse events that required a hospital stay
Measured: 2-year
Hospitalization Times for Related Serious Adverse Events (SAEs)
Hospitalization times for patients with related Serious Adverse Events (SAEs). For patients who were followed up to 2 years after procedure.
Measured: From date of hospitalization for SAE. Patients were followed up to 2 years.
Patient-reported Quality of Life: Yes/No
Patient-reported quality of life assessed by completion of a questionaire
Measured: 2-year
Patient Reported Quality of Life-Pain Questions
Patient reported quality of life related to pain
Measured: 2-year follow-up
Patient Reported Quality of Life-abdominal Wall
patient reported quality of life related to abdominal wall
Measured: 2-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Nov 2020
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral HerniaStudies 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Biotech Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294446
- Sponsor's protocol ID
- 19-004
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2020
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Study of the Biodesign® Hernia Graft
- ClinicalTrials.gov ID
- NCT04294446
- Acronym / sponsor ID
- 19-004
- Conditions
- Ventral Hernia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Cook Biotech IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair.
Detailed description
This multicenter, open-label, prospective clinical study will evaluate the performance of the Biodesign Hernia Graft to reinforce soft tissues during ventral hernia repair.
This post-market study will enroll up to 95 patients at up to 10 clinical sites. Each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. There is no minimum enrollment number per site.
This study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the Biodesign Hernia Graft. The inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the IFU so that the results from this study can provide data on the real-world use of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who meet all of the inclusion criteria and none of the exclusion criteria will be invited to participate in this study.
Key inclusion criteria (1 listed)
- 1. Primary or recurrent ventral hernia in need of surgical repair utilizing a Biodesign Hernia Graft
Key exclusion criteria (6 listed)
- Known sensitivity to porcine material
- Age < 18 years
- Unable or unwilling to provide informed consent
- Life expectancy of less than one year from the date of the index procedure
- Patients will be excluded from the study if they never receive a Biodesign Hernia Graft during their 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 |
|---|---|---|
| Biodesign Hernia GraftThe Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe. | Device | – |
Primary outcome
Hernia Recurrence
Time frame: 1-year
Hernia recurrence through 1-year follow-up
8 secondary outcomes
Device-, Procedure-, and Hernia-related Adverse Event Rates
Time frame: 2-year
Hernia Recurrence Rate Through 2-year Follow-up
Time frame: 2-year
Operative Times
Time frame: During operation
Hospital Stays for Serious Adverse Events
Time frame: 2-year
Hospitalization Times for Related Serious Adverse Events (SAEs)
Time frame: From date of hospitalization for SAE. Patients were followed up to 2 years.
Patient-reported Quality of Life: Yes/No
Time frame: 2-year
Patient Reported Quality of Life-Pain Questions
Time frame: 2-year follow-up
Patient Reported Quality of Life-abdominal Wall
Time frame: 2-year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by Cook Biotech Incorporated at 3 sites in 2 countries.
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 1 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: stopped early, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, 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?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hernia Recurrence (time frame: 1-year). 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 12 Mar 2026.