Veritas in Non-Bridging Ventral Hernia Repair
VIBE
1 other identifier
observational
20
1 country
4
Brief Summary
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2011
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
August 31, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedJanuary 23, 2018
January 1, 2018
6 years
August 29, 2011
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 Years
Secondary Outcomes (2)
Number of Medical and Surgical Complications
2 years
Change in Quality of Life
Baseline to 2 Years
Study Arms (1)
Veritas Collagen Matrix
Observational study of subjects who undergo open ventral hernia repair using Veritas Collagen Matrix in an underlay technique.
Eligibility Criteria
Study surgeons will recruit patients from within their own practice, or through their typical referring sources.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baxter Healthcare Corporationlead
- Synovis Surgical Innovationscollaborator
Study Sites (4)
Mayo Clinic Department of Surgery
Jacksonville, Florida, 32224, United States
Watson Clinic Center for Research
Lakeland, Florida, 33805, United States
Atlanta Colon & Rectal Surgery, P.A.
Atlanta, Georgia, 30274, United States
Pratt Medical Center
Fredericksburg, Virginia, 22407, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2011
First Posted
August 31, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
January 23, 2018
Record last verified: 2018-01