A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

C. R. Bard

Status

Completed

Conditions

Incisional Hernia

Ventral Hernia

Treatments

Device: Resorbable Mesh

Study type

Interventional

Funder types

Industry

Identifiers

DVL-HE-015

Details and patient eligibility

About

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

Full description

Pilot Study of patients across all wound classes for recurrence

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject or subject's legally authorized representative must be willing to give written informed consent
Subject must be diagnosed with ventral or incisional hernia
Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion criteria

Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
Subject's hernia has recurred four or more times.
Subject's body mass index (BMI) >40 kg/m2.
Subject has peritonitis.
Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
Chronic steroid use or immunosuppression drugs (> 6 months).
Subject has cirrhosis, and/or ascites.
Subject is American Society of Anesthesiology Class 4 or 5.
Subject is pregnant or planning to become pregnant during the course of the study.
Subject is known to be infected with human immunodeficiency virus (HIV).
Subject has a life expectancy of less than 2 years at the time of enrollment.
Subject has been treated with an investigational product in the past 30 days.
Subject is part of the site personnel directly involved with this study
Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements