Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

C. R. Bard

Status

Completed

Conditions

Hernia, Incisional

Hernia, Abdominal

Hernia

Treatments

Device: Phasix™ Mesh

Study type

Interventional

Funder types

Industry

Identifiers

NCT02720042

DVL-HE-016

Details and patient eligibility

About

The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

Full description

Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.

Enrollment

84 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject must be diagnosed with incisional midline hernia.
Subject has a VHWG Grade 3 hernia (as defined in the protocol).
Size of hernia ≥ 10 cm2.
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.

Exclusion criteria

Subject with > 4 previous repairs of the hernia under observation.
Body Mass Index (BMI) > 35 kg/m2.
The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
The subject has peritonitis.
Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
The subject has cirrhosis of the liver and/or ascites.
Subject is American Society of Anesthesiology Class 4 or 5.
Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
Subject has intact permanent mesh adjacent to the current hernia to be repaired.
Subject's hernia repair requires intraabdominal mesh placement.
Surgical technique requires surgical bridge repair as the sole repair.
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.
Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature.
Subject is part of the site personnel directly involved with this study.
Subject has a life expectancy of less than 2 years at the time of enrollment.
Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).