NCT03495154

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2022

Completed
4 months until next milestone

Results Posted

Study results publicly available

November 17, 2022

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

3.1 years

First QC Date

March 27, 2018

Results QC Date

July 20, 2022

Last Update Submit

April 2, 2024

Conditions

Ventral Hernia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair

    12 months post surgery

Secondary Outcomes (2)

  • Number of Participants With Incidence of Adverse Device Effects (ADEs) Intra-operatively, at Discharge, Within 1 Month, 3 Months, 12 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair.

    operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery

  • Number of Participants With Incidence of Hernia Recurrence at 1 Month, 3 Months and 24 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair

    1 month, 3 months, and 24 months post-surgery

Study Arms (1)

Parietene DS Composite Mesh

EXPERIMENTAL

Patients treated with Parietene DS Composite Mesh

Device: Parietene DS Composite Mesh

Interventions

Parietene DS Composite MeshDEVICE

All subjects enrolled will receive the Parietene DS Composite Mesh

Parietene DS Composite Mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • BMI \> 45 kg/m2
  • Subject is undergoing emergency surgery
  • Subject is pregnant or planning to become pregnant during study participation period
  • Subject is unable or unwilling to comply with the study requirements or follow-up schedule
  • 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
  • The subject has participated in another investigational drug or device research study within 30 days of enrollment
  • Subject has a parastomal hernia
  • Subject's hernia repair is in a contaminated or infected site (CDC wound class 2-4) as assessed by the Investigator(s)
  • Subject is undergoing "bridging" repair technique with the mesh placed in an "inlay" position
  • Surgeon is unable to completely remove existing mesh from prior surgery
  • Surgeon overlays 2 meshes
  • Subject receives any mesh other than Parietene™ DS composite mesh

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Our Lady of the Lakes Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

University of Missouri - Columbia

Columbia, Missouri, 65201, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Hernia Center of Excellence LLC

Newport News, Virginia, 23606, United States

Location

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

There were no limitations or caveats in this study.

Results Point of Contact

Title
Alyssa Sutch, Senior Clinical Research Specialist
Organization
Medtronic
alyssa.m.sutch@medtronic.com
612-214-9756

Study Officials

  • Sue Kim

    Medtronic - Surgical Innovations

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All subjects enrolled will receive the Parietene DS Composite Mesh
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2018

First Posted

April 11, 2018

Study Start

June 21, 2018

Primary Completion

July 21, 2021

Study Completion

July 6, 2022

Last Updated

April 23, 2024

Results First Posted

November 17, 2022

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(6)