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

Study results available
· View outcomes & findings →

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

More Related Trials

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 NCT01961687 on ClinicalTrials.gov