MedTrace Logo

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

NCT03495154 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-04-23

Study results available
· View outcomes & findings →

Summary

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)

Conditions

  • Ventral Hernia

Interventions

DEVICE

Parietene DS Composite Mesh

All subjects enrolled will receive the Parietene DS Composite Mesh

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Sue Kim · Medtronic - Surgical Innovations

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2021-07-21
Completion
2022-07-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03495154 on ClinicalTrials.gov