A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.
NCT01961687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2021-01-26
Summary
Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.
Conditions
- Ventral Hernia
- Incisional Hernia
Interventions
- DEVICE
-
Resorbable Mesh
Phasix Mesh
Sponsors & Collaborators
-
FGK Clinical Research GmbH
collaborator INDUSTRY -
C. R. Bard
lead INDUSTRY
Principal Investigators
-
Scott Roth, MD · University of Kentucky
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2020-01-27
- Completion
- 2020-01-27
Countries
- United States
Study Locations
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