N/A
N=119
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT00866814 ↗Enrolled (actual)
119
Serious AEs
6.7%
Results posted
May 2012
Primary outcome: Primary: The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. — 0 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Bard Ventrio Hernia Patch (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- C. R. Bard
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. |
— | — |
| SECONDARY Perioperative Complications Will be Assessed by Evaluation of the Procedural and Device Related Adverse Events (AEs) Collected From the Time Surgery is Initiated Until the Day the Patient is Discharged From the Hospital. |
4 | — |
| SECONDARY Short-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected From the Day After the Patient is Discharged From the Hospital Until 21 Days Post Procedure. |
10 | — |
| SECONDARY Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year. |
6 | — |
| SECONDARY Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey |
0.7; 0.3; 0.1; 1.3; 1.6; 0.3 | — |
| SECONDARY Procedure Time |
42.8 | — |
Summary
This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.
Eligibility Criteria
Inclusion Criteria
- Male or female, age ≥ 18
- Be able to undergo study procedures
- Have signed an Informed Consent form (ICF)
- Be diagnosed with a ventral hernia requiring an open surgery for repair.
Exclusion Criteria
- Patient is participating in another device or drug study.
- Patient exhibits clinical symptoms indicating infected hernia site.
- Patient currently has a clean contaminated or contaminated site.
- Patient has a life expectancy less than 2 years at the time of enrollment.
- Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.
Data sourced from ClinicalTrials.gov (NCT00866814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.