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

Study results available
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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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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 NCT01863030 on ClinicalTrials.gov