A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

Completed

Conditions studied: Ventral Hernia

In brief

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 ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery. 2. Perioperative, short-term and long-term procedural and/or device related complications. 3. Abdominal Wall Function and mobility.

Key facts

Study ID

NCT01863030

Run by

John Roth

People needed

31

Starts

2013-05-01

Expected to finish

2016-11-01

Last updated by the study team

2020-01-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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