A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix Mesh for VHWG Grade 3 Midline Hernia Repair - Phasix mesh for the treatment of VHWG Grade 3 Midline Hernia Repair

Davol Inc.0 sites14 target enrollmentTBD

Overview

Trial is onging in other countries

Registry

who.int

Start Date

TBD

End Date

June 20, 2019

Last Updated

2 years ago

Study Type

Interventional

Sponsor

Davol Inc.

•The subject must meet all of the criteria listed below to be enrolled in the study:
•1\. Subject must be 18 years of age or older.
•2\. Subject must be diagnosed with incisional midline hernia.
•3\. Subject has a VHWG Grade 3 hernia (as defined in 5\.2\.3\).
•4\. Size of hernia \* 10 cm2\.
•5\. Subject must be willing to undergo a planned retro\-rectus hernia repair (onlay allowed as an exception when retro\-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique (CST).
•6\. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study\*s provisions, and has duly signed the informed consent form (ICF). Subject agrees to comply with the protocol\-mandated procedures and visits.

•The subject must be excluded from study enrollment if any of the following criteria are met:
•1\. Subject with \> 4 previous repairs of the hernia under observation.
•2\. Body Mass Index (BMI) \> 35 kg/m2\.
•3\. The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
•4\. The subject has peritonitis.
•5\. Known human immunodeficiency virus (HIV) infection (if documented in the subject\*s record).
•6\. The subject has cirrhosis of the liver and/or ascites.
•7\. Subject is American Society of Anesthesiology Class 4 or 5\.
•8\. Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
•9\. The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).