HerniaVIBENCT01426477
Veritas in Non-Bridging Ventral Hernia Repair
An observational study of Hernia, run by Baxter Healthcare Corporation at 4 sites in United States.
Trial summary
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia
- How many people
- 20 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study surgeons will recruit patients from within their own practice, or through their typical referring sources.
Who may be able to join
- Must be 18 years of age or older
- Ability to understand and read English
- Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation
- Must be of ambulatory status
- Primary closure can be obtained during surgery
- Repair is such that one piece of Veritas can be used to reinforce the repair
Who cannot join
- Hernia is undetectable on physical exam
- There is evidence of existing cancer
- BMI ≥ 40
- Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents
- Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Atlanta Colon & Rectal Surgery, P.A.
Atlanta, Georgia, 30274
Pratt Medical Center
Fredericksburg, Virginia, 22407
Mayo Clinic Department of Surgery
Jacksonville, Florida, 32224
Watson Clinic Center for Research
Lakeland, Florida, 33805
About this study
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
- Conditions
- Hernia
- Keywords
- Ventral hernia, Abdominal wall hernia, Incisional hernia, Biologic mesh, Veritas Collagen Matrix, Veritas
- Medical subject headings
- Hernia, Hernia, Ventral, Hernia, Abdominal, Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veritas Collagen Matrix | Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence
Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, and 2 years), or when patients present with symptoms, with primary endpoint at 2 years.
Measured: 2 Years
Secondary outcomes (2)
Number of Medical and Surgical Complications
Medical and Surgical Complications, including seroma, wound infection or other concurrent infection, hematoma, fistula, ileus, skin necrosis, wound dehiscence, or any other device-related events, will be evaluated through physical exam and/or CT scans at 30 days, 6 months, 1 year, and 2 years, or when patients present with symptoms. These will be reported as total number of each complication within the total number of patients.
Measured: 2 years
Change in Quality of Life
Patients will complete questionnaires regarding physical functioning including activities of daily living, work productivity, and patient comfort at various timepoints after implant at baseline, and at all follow-up visits. Outcomes will be reported in the change from baseline to 2-years.
Measured: Baseline to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426477
- Sponsor's protocol ID
- 09-004
- Acronym
- VIBE
- Status last verified
- Jan 2018
- First submitted
- 29 Aug 2011
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Veritas in Non-Bridging Ventral Hernia Repair
- ClinicalTrials.gov ID
- NCT01426477
- Acronym / sponsor ID
- VIBE / 09-004
- Conditions
- Hernia
- Keywords
- Ventral hernia, Abdominal wall hernia, Incisional hernia, Biologic mesh, Veritas Collagen Matrix, Veritas
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Synovis Surgical Innovations
- Study start
- Aug 2011
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 31 Aug 2011 (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 main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Veritas Collagen Matrix | – | –Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study surgeons will recruit patients from within their own practice, or through their typical referring sources.
Key inclusion criteria (6 listed)
- Must be 18 years of age or older
- Ability to understand and read English
- Must be scheduled for open abdominal surgery for repair of primary ventral hernia or first recurrence of a ventral hernia with the Veritas Collagen Matrix using the underlay technique, with our without component separation
- Must be of ambulatory status
- Primary closure can be obtained during surgery
Key exclusion criteria (5 listed)
- Hernia is undetectable on physical exam
- There is evidence of existing cancer
- BMI ≥ 40
- Use of chronic immunosuppressive therapy, including steroids or cytotoxic agents
- Any condition that product labeling indicates would adversely affect participant safety, including sensitivity to bovine products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hernia recurrence
Time frame: 2 Years
Recurrence will be evaluated through physical exam and/or CT scans at all study visits (30 days, 6 months, 1 year, and 2 years), or when patients present with symptoms, with primary endpoint at 2 years.
2 secondary outcomes
Number of Medical and Surgical Complications
Time frame: 2 years
Change in Quality of Life
Time frame: Baseline to 2 Years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, run by Baxter Healthcare Corporation at 4 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 6 inclusion and 5 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early. Results are not available in the source record.
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: 2 Years). 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 23 Jan 2018.