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

NCT02720042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2020-09-25

Study results available
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Summary

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.

Conditions

  • Hernia
  • Hernia, Abdominal
  • Hernia, Incisional

Interventions

DEVICE

Phasix™ Mesh

A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Hans Jeekel · Erasmus University Medical Centre Rotterdam

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-23
Primary Completion
2017-07-31
Completion
2019-06-20

Countries

  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02720042 on ClinicalTrials.gov