Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Bard Ventrio Hernia Patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ventrio Group<br>Patients diagnosed with a ventral hernia requiring an open surgery for repair. | Device: Bard Ventrio Hernia Patch<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | 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. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | 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. | In this study, a complication was defined as any adverse event that was assessed by the Investigator as either possibly or definitely related to the study procedure or the study device. | 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 | Mean Quality of Life scores at each study visit for the sensation of mesh, pain, and movement limitation components of the Carolinas Comfort Scale are reported. Patient responses are provided on a ordinal scale from 0-5 indicating increasing severity of symptoms with 0 representing no symptoms and 5 representing disabling symptoms. Sensation of mesh was not evaluable at baseline and therefore, scores are reported starting at 2 weeks post study procedure. | Baseline and post-surgery at week 2, month 6 and month 12 | 
| Procedure Time | Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed. | Day of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia, open