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A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair | Clinical Trials | Clareo Health

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A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair

NCT02053168•C. R. Bard

View on ClinicalTrials.gov

Summary

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

Detailed Description

Pilot Study of patients across all wound classes for recurrence

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+5 more criteria

Locations (6)

Beverly Hills Hernia Center

Beverly Hills, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Florida Hospital Celebration Health

Celebration, Florida, United States

Methodist Physicians Clinic

Omaha, Nebraska, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Oregon Health and Sciences University

Portland, Oregon, United States

Key Dates

Start Date

February 1, 2014

Primary Completion Date

February 23, 2017

Completion Date

February 23, 2017

Last Updated

May 11, 2018

Enrollment

ACTUAL participants

Conditions

Ventral HerniaIncisional Hernia

Interventions

Resorbable Mesh

DEVICE

Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.

NCT07451483

Ventral HerniasCytoreductive Surgery

View study

RECRUITING

Cytokine Response to Abdominal Wall Reconstruction

NCT07422584

Incisional Ventral Hernia

View study

RECRUITINGNA

GORE® ENFORM Biomaterial Product Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Prospective, Multicenter All Comers Study of Phasix Mesh for Ventral or Incisional Hernia Repair

Inclusion Criteria

Exclusion Criteria

Ventral Hernias Following Cytoreductive Surgery : Incidence, Risk Factors and Surgical Management.

Cytokine Response to Abdominal Wall Reconstruction

GORE® ENFORM Biomaterial Product Study

Suture Repair vs Mesh Repair for Incisional Hernia

Does Preoperative Physical Activity Predict Postoperative Complications After Incisional Hernia Repair ?

Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair