Overview

This trial is active, not recruiting.

Conditions ventral hernia, incisional hernia
Treatment resorbable mesh
Phase phase 1/phase 2
Sponsor C. R. Bard
Start date February 2014
End date February 2017
Trial size 30 participants
Trial identifier NCT02053168, DVL-HE-015

Summary

Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Phasix Mesh
resorbable mesh
Phasix Mesh

Primary Outcomes

Measure
Hernia Recurrence Rate
time frame: 12 Months

Secondary Outcomes

Measure
Device related adverse events
time frame: 24 Months
QOL assessments
time frame: 24 Months
Surgical procedure time
time frame: 10 Months
Length of hospital post Index Procedure
time frame: 10 Months
Length of hospital stay
time frame: 10 Months
Number of study related post operative surgical procedures and admissions.
time frame: 24 Months
Number of study related post operative surgical procedure and admissions
time frame: 24 Months
Number of related post-operative visits unrelated to standard of care
time frame: 24 Months
Incidence of seroma
time frame: 24 Months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject or subject's legally authorized representative must be willing to give written informed consent - Subject must be diagnosed with ventral or incisional hernia - Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol. Exclusion Criteria: - Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery). - Subject's hernia has recurred four or more times. - Subject's body mass index (BMI) >40 kg/m2. - Subject has peritonitis. - Subject is on or suspected to be placed on chemotherapy medications during any part of the study. - Chronic steroid use or immunosuppression drugs (> 6 months). - Subject has cirrhosis, and/or ascites. - Subject is American Society of Anesthesiology Class 4 or 5. - Subject is pregnant or planning to become pregnant during the course of the study. - Subject is known to be infected with human immunodeficiency virus (HIV). - Subject has a life expectancy of less than 2 years at the time of enrollment. - Subject has been treated with an investigational product in the past 30 days. - Subject is part of the site personnel directly involved with this study - Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials. - Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements

Additional Information

Official title A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
Principal investigator Yuri Novitsky, MD
Description Pilot Study of patients across all wound classes for recurrence
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.