A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery

John Roth1 site in 1 country31 target enrollmentMay 2013

ConditionsVentral Hernia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ventral Hernia
Sponsor: John Roth
Enrollment: 31
Locations: 1
Primary Endpoint: Number of Participants With Recurrent Ventral and Incision Hernias Post Repair With Phasix™ Mesh
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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:

Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh for up to 12 months post surgery.
Perioperative, short-term and long-term procedural and/or device related complications.
Abdominal Wall Function and mobility.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

November 2016

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

John Roth

Responsible Party

Sponsor Investigator

Principal Investigator

John Roth

University of Kentucky

Eligibility Criteria

Inclusion Criteria

•The subject must meet all of the relevant criteria listed below to be enrolled in the study:
•Subject must be ≥18 years of age.
•Subject or subject's legally authorized representative must be willing give written informed consent.
•Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia.
•Hernia size greater than 10cm2 and less than 250cm2
•Subject must be willing to undergo ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.

Exclusion Criteria

•The subject must be excluded from study enrollment if any of the following criteria are met:
•Subject's hernia is multiply recurrent.
•CDC wound classification other than clean or clean-contaminated
•The use of surgical repair as a bridge.
•Patient has a contraindication to placement of mesh.
•Concomitant procedures with wound classification other than clean
•Subject has peritonitis.
•Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
•Subject's body mass index (BMI) \>55 kg/m
•Subject has cirrhosis, and/or ascites.