Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch
A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch
1 other identifier
observational
119
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2009
Typical duration for all trials
7 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
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 20, 2009
CompletedFirst Posted
Study publicly available on registry
March 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
May 21, 2012
CompletedOctober 12, 2012
October 1, 2012
2.2 years
March 20, 2009
April 19, 2012
October 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
A recurrent hernia is a hernia, confirmed by the investigator at any point within the first year after surgery, in the same location as the hernia repaired in the index procedure.
1 year post surgery
Secondary Outcomes (5)
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.
From the time of surgery to hospital discharge, an average of 1-2 days
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.
Hospital discharge through 21 days post surgery
Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.
22 days post surgery through 1 year post surgery
Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey
Baseline and post-surgery at week 2, month 6 and month 12
Procedure Time
Day of surgery
Study Arms (1)
Ventrio Group
Patients diagnosed with a ventral hernia requiring an open surgery for repair.
Interventions
The Ventrio Hernia Patch is a self-expanding, non-absorbable, sterile prosthesis for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Eligibility Criteria
Subjects with a diagnosis of ventral hernia will be screened for eligibility against the study protocol inclusion and exclusion criteria utilizing standard preoperative criteria (e.g. physical examination, blood work, medical evaluation, etc) which occurred within 30 days of the date of consent.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- C. R. Bardlead
- FGK Clinical Research GmbHcollaborator
Study Sites (7)
Sutter Medical Group GNS
Sacramento, California, United States
Sacred Heart Health System, Inc.
Pensacola, Florida, 32504, United States
RUSH Univeristy Medical Center
Chicago, Illinois, United States
Associated Surgical Group
Peoria, Illinois, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
Novant Clinical Research Institute
Winston-Salem, North Carolina, 27103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was designed as a single arm observational trial without predefined statistical hypotheses (theories) to test; therefore, data can only be described and no treatment comparisons or conclusions can be made.
Results Point of Contact
- Title
- Dawn Heimer/Director, Clinical Affairs
- Organization
- C.R. Bard: Davol, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
David Iannitti, MD, FACS
Carolinas Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2009
First Posted
March 23, 2009
Study Start
March 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
October 12, 2012
Results First Posted
May 21, 2012
Record last verified: 2012-10