Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

October 10, 2012 updated by: C. R. Bard

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year post surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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.
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.
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.
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.
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.
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
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.
Baseline and post-surgery at week 2, month 6 and month 12
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.
Day of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FGK Clinical Research GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Iannitti, MD, FACS, Carolinas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DVL-HE004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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