A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
NCT01863030 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31
Last updated 2020-01-21
Summary
The objective of this study is to collect efficacy, safety and utility data with Phasix™ Mesh in ventral and incisional repair procedures by evaluating the following:
1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
2. Perioperative, short-term and long-term procedural and/or device related complications.
3. Abdominal Wall Function and mobility.
Conditions
- Ventral Hernia
Interventions
- DEVICE
-
Phasix mesh implant
Sponsors & Collaborators
-
John Roth
lead OTHER
Principal Investigators
-
John S Roth, MD · University of Kentucky
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-05-31
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
Countries
- United States
Study Locations
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