Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

This study has been completed.
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT00866814
First received: March 20, 2009
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Ventral Hernia
Device: Bard Ventrio Hernia Patch

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Single Arm, Multi-Center Study Of Open Ventral Hernia Repair Utilizing The Bard Ventrio Hernia Patch

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • The Primary Endpoint is the Rate of Hernia Recurrence in Study Patients. [ Time Frame: 1 year post surgery ] [ Designated as safety issue: No ]
    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 Outcome 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Procedure time will be defined as beginning when the investigator makes the initial incision and ending when the skin closure is completed.


Enrollment: 119
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866814

Locations
United States, California
Sutter Medical Group GNS
Sacramento, California, United States
United States, Florida
Sacred Heart Health System, Inc.
Pensacola, Florida, United States, 32504
United States, Illinois
RUSH Univeristy Medical Center
Chicago, Illinois, United States
Associated Surgical Group
Peoria, Illinois, United States
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
Novant Clinical Research Institute
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
C. R. Bard
FGK Clinical Research GmbH
Investigators
Principal Investigator: David Iannitti, MD, FACS Carolinas Medical Center
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00866814     History of Changes
Other Study ID Numbers: DVL-HE004
Study First Received: March 20, 2009
Results First Received: April 19, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by C. R. Bard:
hernia
open

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 23, 2014