Status:
COMPLETED
A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Lead Sponsor:
John Roth
Conditions:
Ventral Hernia
Eligibility:
All Genders
18-100 years
Brief Summary
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following: 1. Hernia recurrence rate of ven...
Eligibility Criteria
Inclusion
- The subject must meet all of the relevant criteria listed below to be enrolled in the study:
- Subject must be ≥18 years of age.
- Subject or subject's legally authorized representative must be willing give written informed consent.
- Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
- Hernia size greater than 10cm2 and less than 250cm2
- Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.
Exclusion
- The subject must be excluded from study enrollment if any of the following criteria are met:
- Subject's hernia is multiply recurrent.
- CDC wound classification other than clean or clean-contaminated
- The use of surgical repair as a bridge.
- Patient has a contraindication to placement of mesh.
- Concomitant procedures with wound classification other than clean
- Subject has peritonitis.
- Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
- Subject's body mass index (BMI) \>55 kg/m2.
- Subject has cirrhosis, and/or ascites.
- Subject is American Society of Anesthesiology Class 4 or 5.
- Subject is known to be infected with human immunodeficiency virus (HIV).
- Subject has known allergies to tetracycline or kanamycin.
- Subject has a life expectancy of less than 2 years at the time of enrollment.
- Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01863030
Start Date
May 1 2013
End Date
November 1 2016
Last Update
January 21 2020
Active Locations (1)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536