Davol Phasix EU Study DVL-HE-016
Research type
Research Study
Full title
A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
IRAS ID
201111
Contact name
Alastair Windsor
Contact email
Sponsor organisation
Davol Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 1 months, 1 days
Research summary
Phasix™ Mesh provides a physical barrier to fat or organ protrusion where patients have a hernia. The Phasix™ Mesh has been approved for use in the European market and carries the European Conformity (CE) mark and is intended to be used for the support of soft tissue where weakness exists, such as the repair of hernias. The mesh is made from a natural material that is resorbed by the body slowly over time.
The purpose of this study is to collect data on the use of Phasix™ Mesh in hernia repair procedures of complex hernias by assessing if the patients' hernias comes back, if they have pain and discomfort, and information on the patients' general quality of life.
Given the fact that the current literature still is rather void of evidence-based guidelines regarding optimal choice of mesh, this clinical investigation may contribute to deliver evidence on optimal choice of mesh materials in complex hernias based on the data gained from this clinical study.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0129
Date of REC Opinion
20 Apr 2016
REC opinion
Further Information Favourable Opinion