Trials / Completed
CompletedNCT02720042
Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
A Post-Market, Prospective, Multi-Center, Single-Arm Clinical Investigation of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Phasix™ Mesh | A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB) |
Timeline
- Start date
- 2016-03-23
- Primary completion
- 2017-07-31
- Completion
- 2019-06-20
- First posted
- 2016-03-25
- Last updated
- 2020-09-25
- Results posted
- 2020-06-17
Locations
15 sites across 8 countries: Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT02720042. Inclusion in this directory is not an endorsement.