ClinicalTrials.Veeva

Menu

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

C

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

84 participants in 1 patient group

Phasix™ Mesh
Experimental group
Description:
Patients treated with Phasix™ Mesh for hernia repair
Treatment:
Device: Phasix™ Mesh

Trial documents
2

Trial contacts and locations

15

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems