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

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.

Study Overview

• Status: Completed
• Conditions: Ventral Hernia
• Intervention / Treatment: Device: Bard Ventrio Hernia Patch

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States
      • Sutter Medical Group GNS
  • Florida
    • Pensacola, Florida, United States, 32504
      • Sacred Heart Health System, Inc.
  • Illinois
    • Chicago, Illinois, United States
      • Rush Univeristy Medical Center
    • Peoria, Illinois, United States
      • Associated Surgical Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Medical Center
    • Gastonia, North Carolina, United States, 28054
      • Gaston Memorial Hospital
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ventrio Group; Patients diagnosed with a ventral hernia requiring an open surgery for repair.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: FGK Clinical Research GmbH
• Investigators: Principal Investigator: David Iannitti, MD, FACS, Carolinas Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: March 20, 2009
• First Submitted That Met QC Criteria: March 20, 2009
• First Posted (Estimate): March 23, 2009

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: hernia; open
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: DVL-HE004