TerminatedInterventionalPhase 4Updated Nov 20, 2013
Veritas in Non-Bridging Ventral Hernia Repair | NCT01426477 | Trialant
TerminatedObservationalUpdated Jan 23, 2018
Veritas in Non-Bridging Ventral Hernia Repair
Veritas in Non-Bridging Ventral Hernia Repair
ClinicalTrials.gov ID
NCT01426477
Lead Sponsor
Baxter Healthcare CorporationINDUSTRY
Overall Status
Terminated
Study Type
Observational
Enrollment
20Actual
Last Update Posted
Jan 23, 2018Actual
Start Date
Aug 2011
Primary Completion Date
Aug 2017Actual
Completion Date
Aug 2017Actual
Official Title
Veritas in Non-Bridging Ventral Hernia Repair
Brief Summary
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
Hernia
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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