Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Overview

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.

Full Title of Study: “A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2011

Interventions

  • Device: Bard Ventrio Hernia Patch
    • 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.

Arms, Groups and Cohorts

  • Ventrio Group
    • Patients diagnosed with a ventral hernia requiring an open surgery for repair.

Clinical Trial Outcome Measures

Primary Measures

  • The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients.
    • Time Frame: 1 year post surgery
    • 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.

Secondary Measures

  • 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.
    • Time Frame: From the time of surgery to hospital discharge, an average of 1-2 days
    • 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.
  • 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.
    • Time Frame: Hospital discharge through 21 days post surgery
    • 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.
  • Long-term Complications Will be Assessed by Evaluation of the Procedural and Device Related AEs Collected After 21 Days up to 1 Year.
    • Time Frame: 22 days post surgery through 1 year post surgery
    • 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.
  • Quality of Life Will be Assessed at Baseline Through 1 Year Utilizing the Carolinas Comfort Scale Survey
    • Time Frame: Baseline and post-surgery at week 2, month 6 and month 12
    • 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.
  • Procedure Time
    • Time Frame: Day of surgery
    • Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female, age ≥ 18 2. Be able to undergo study procedures 3. Have signed an Informed Consent form (ICF) 4. Be diagnosed with a ventral hernia requiring an open surgery for repair. Exclusion Criteria:

1. Patient is participating in another device or drug study. 2. Patient exhibits clinical symptoms indicating infected hernia site. 3. Patient currently has a clean contaminated or contaminated site. 4. Patient has a life expectancy less than 2 years at the time of enrollment. 5. 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • C. R. Bard
  • Collaborator
    • FGK Clinical Research GmbH
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Iannitti, MD, FACS, Principal Investigator, Carolinas Medical Center

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