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Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair | Clinical Trials | Clareo Health

COMPLETEDNA

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair

NCT03495154•Medtronic - MITG

View on ClinicalTrials.gov

Summary

Detailed Description

A multi-center post-market single arm prospective study of Parietene™ DS Composite Mesh in subjects undergoing ventral hernia repair to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months) 125 male or female adults subjects will be enrolled in a minimum of 4 USA sites who are undergoing elective ventral hernia repair (primary or incisional)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has provided informed consent
•2. Subject is ≥18 years of age (at the time of consent)
•3. Subject is undergoing elective ventral hernia repair (primary or incisional) with intraperitoneal mesh placement

Exclusion Criteria

•1. BMI \> 45 kg/m2
•2. Subject is undergoing emergency surgery
•3. Subject is pregnant or planning to become pregnant during study participation period
•4. Subject is unable or unwilling to comply with the study requirements or follow-up schedule
•5. Subject has comorbidities which, in the opinion of the Investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months
•6. The subject has participated in another investigational drug or device research study within 30 days of enrollment
•7. Subject has a parastomal hernia
•1. Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
•2. Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
•3. Surgeon is unable to completely remove existing mesh from prior surgery
+2 more criteria

Locations (6)

Our Lady of the Lakes Regional Medical Center

Baton Rouge, Louisiana, United States

University of Missouri - Columbia

Columbia, Missouri, United States

The Ohio State University

Columbus, Ohio, United States

Hernia Center of Excellence LLC

Newport News, Virginia, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Key Dates

Start Date

June 21, 2018

Primary Completion Date

July 21, 2021

Completion Date

July 6, 2022

Last Updated

April 23, 2024

Enrollment

145

ACTUAL participants

Conditions

Ventral Hernia

Interventions

Parietene DS Composite 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

ACTIVE_NOT_RECRUITINGNA

Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

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: April 23, 2024Data 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

Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair

Inclusion Criteria

Exclusion Criteria

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

Cytokine Response to Abdominal Wall Reconstruction

Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

Emergency Hernia Repair

Open Versus Robotic Retromuscular Ventral Hernia Repair

Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair