Overview

This trial is active, not recruiting.

Condition ventral hernia
Treatment phasix mesh implant
Phase phase 4
Sponsor John Roth
Start date May 2013
End date August 2015
Trial size 30 participants
Trial identifier NCT01863030, Phasix

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Mesh being used for approved use. Mesh for ventral and incisional hernias.
phasix mesh implant

Primary Outcomes

Measure
1. Hernia recurrence rate of ventral and incisional hernias post repair with Phasix™ Mesh
time frame: up to 12 months post surgery

Secondary Outcomes

Measure
2. Perioperative, short-term and long-term procedural and/or device related complications
time frame: up to 12 months post surgery

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: The subject must meet all of the relevant criteria listed below to be enrolled in the study: 1. Subject must be ≥18 years of age. 2. Subject or subject's legally authorized representative must be willing give written informed consent. 3. Subject must be diagnosed with a ventral, incisional or first-recurrent incisional hernia. 4. Hernia size greater than 10cm2 and less than 250cm2 5. 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: 1. Subject's hernia is multiply recurrent. 2. CDC wound classification other than clean or clean-contaminated 3. The use of surgical repair as a bridge. 4. Patient has a contraindication to placement of mesh. 5. Concomitant procedures with wound classification other than clean 6. Subject has peritonitis. 7. Subject is on or suspected to be placed on chemotherapy medications during any part of the study. 8. Subject's body mass index (BMI) >55 kg/m2. 9. Subject has cirrhosis, and/or ascites. 10. Subject is American Society of Anesthesiology Class 4 or 5. 11. Subject is known to be infected with human immunodeficiency virus (HIV). 12. Subject has known allergies to tetracycline or kanamycin. 13. Subject has a life expectancy of less than 2 years at the time of enrollment. 14. Subject has any condition in the opinion of the Investigator that would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.

Additional Information

Official title A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair Surgery
Principal investigator John S Roth, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Kentucky.