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

Completed · Not applicable

Conditions studied: Ventral Hernia, Incisional Hernia

In brief

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

Key facts

Study ID: NCT02053168
Run by: C. R. Bard
People needed: 33
Starts: 2014-02-01
Expected to finish: 2017-02-23
Last updated by the study team: 2018-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

Beverly Hills Hernia Center — Beverly Hills, California, United States
Cedars-Sinai Medical Center — Los Angeles, California, United States
Florida Hospital Celebration Health — Celebration, Florida, United States
Methodist Physicians Clinic — Omaha, Nebraska, United States
University Hospitals Case Medical Center — Cleveland, Ohio, United States
Oregon Health and Sciences University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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