Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

C. R. Bard

Status: Completed

Conditions: Ventral Hernia

Treatments: Device: Bard Ventrio Hernia Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT00866814

DVL-HE004

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

119 participants in 1 patient group

Ventrio Group

Description:

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

Treatment:

Device: Bard Ventrio Hernia Patch