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Completed

NCT Number: NCT00866814

Study Of 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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sutter Medical Group GNS, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bard Ventrio Hernia Patch

Device

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Collaborators

  • FGK Clinical Research GmbH

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2009
Registry last updated
Oct 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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