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Composite Mesh

Parietene DS Composite Mesh for Ventral Hernia (PPDS Trial)

N/A
Waitlist Available
Research Sponsored by Medtronic - MITG
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
Awards & highlights

PPDS Trial Summary

This trial is testing a new type of mesh to see if it is safe and effective for repairing ventral hernias.

Eligible Conditions
  • Ventral Hernia

PPDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Secondary outcome measures
Carolinas Comfort Scale™ Quality of Life Questionnaire Completed Pre-operatively and at 1 Month,12 Months and 24 Months Post-operatively
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.
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
+2 more

PPDS Trial Design

1Treatment groups
Experimental Treatment
Group I: Parietene DS Composite MeshExperimental Treatment1 Intervention
Patients treated with Parietene DS Composite Mesh
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Parietene DS Composite Mesh
2018
N/A
~150

Find a Location

Who is running the clinical trial?

Medtronic - MITGLead Sponsor
252 Previous Clinical Trials
300,541 Total Patients Enrolled
Sue KimStudy DirectorMedtronic - Surgical Innovations

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
2018. "Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03495154.
~21 spots leftby Apr 2025
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