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Completed

NCT Number: NCT03495154

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 to confirm its clinical safety and performance in the short (1, 3 months), mid (12 months) and long term (24 months)

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Our Lady of the Lakes Regional Medical Center, Baton Rouge, Louisiana, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preoperative Inclusion Criteria
  • 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

Exclusion criteria

  • Preoperative Exclusion Criteria
  • 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
  • Intra-operative Exclusion Criteria
  • 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

Treatment and study plan

Parietene DS Composite Mesh

Device

All subjects enrolled will receive the Parietene DS Composite Mesh

Primary outcomes

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

    Time frame: 12 months post surgery

Secondary outcomes

  1. 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.

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

  2. 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

    Time frame: 1 month, 3 months, and 24 months post-surgery

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: PPDS

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 11, 2018
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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