Clinical Trials

Sponsor(s): C. R. Bard, FGK Clinical Research GmbH

Condition(s):

Abdominal Hernia
Hernia
Hernia, Abdominal

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.

Eligibility:

Minimum Age:

18 Years

Accepts Healthy Volunteers:

No

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.

Other Location(s): Sacramento, California United States,San Francisco, California United States,Pensacola, Florida United States,Peoria, Illinois United States,Chicago, Illinois United States,Charlotte, North Carolina United States,Winston-Salem, North Carolina United States,Gastonia, North Carolina United States

Terms: This is an abstract courtesy of ClinicalTrials.gov, a service of the US National Institute of Health Developed by the National Library of Medicine. ClinicalTrials.gov provides regularly updates information about federally and privately supported clinical research in human volunteers.