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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495154
Recruitment Status : Active, not recruiting
First Posted : April 11, 2018
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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)

Condition or disease Intervention/treatment Phase
Ventral Hernia Device: Parietene DS Composite Mesh Not Applicable

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: All subjects enrolled will receive the Parietene DS Composite Mesh
Primary Purpose: Treatment
Official Title: A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
Actual Study Start Date : June 21, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Parietene DS Composite Mesh
Patients treated with Parietene DS Composite Mesh
Device: Parietene DS Composite Mesh
All subjects enrolled will receive the Parietene DS Composite Mesh




Primary Outcome Measures :
  1. Incidence of hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair [ Time Frame: 12 months post surgery ]
    Hernia recurrence


Secondary Outcome Measures :
  1. - Incidence of adverse device effects (ADEs) and procedure related adverse events intra-operatively, within 1 month, 3 months, 12 months, and 24 months following Parietene™ DS Composite mesh use in ventral hernia repair [ Time Frame: operation, 1 month,3 months, 12 months, 24 months post surgery ]
    adverse device effects (ADEs) and procedure related adverse events

  2. - Incidence of hernia recurrence at 1, 3 and 24 months. The evaluation of hernia recurrence will be performed during a physical examination [ Time Frame: 1 month, 3 months, 24 months post surgery ]
    Hernia recurrence

  3. - Time to hernia recurrence [ Time Frame: up to 2 years post surgery ]
    - Time to hernia recurrence (from surgery timepoint)

  4. - Carolinas Comfort Scale™ Quality of life questionnaire completed pre-operatively and at 1, 12 and 24 months postoperatively [ Time Frame: pre-operatively, 1 month, 12 months, 24 months post surgery ]
    The Carolina Comfort scale is a question survey used to assess a patient's quality of life pre and post hernia repair with mesh. Each question is scored on a scale of 0-5 with 0 indicating no symptoms and 5 indicating disabling symptoms The Carolina comfort scale is a 15-item (pre-operative assessment) or a 23-item (post-operative assessment), Likert-type questionnaire that measures severity of pain, sensation of mesh (post-operative assessment only), and movement limitations in the following eight categories: lying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking, stairs, and exercise. The CCS score is derived by adding the scores from each of the 15 or 23 items. The best possible score is 0 and the worst possible score is 115.

  5. - Time to adverse device effect occurence [ Time Frame: up to 2 years post surgery ]
    -Time to adverse device effect occurrence (from surgery timepoint)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preoperative 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:

  • Preoperative 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
  • Intra-operative Exclusion Criteria

    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
    4. Surgeon overlays 2 meshes
    5. Subject receives any mesh other than Parietene™ DS composite mesh

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495154


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
Our Lady of the Lakes Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
United States, Missouri
University of Missouri - Columbia
Columbia, Missouri, United States, 65201
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Virginia
Hernia Center of Excellence Llc
Newport News, Virginia, United States, 23606
United States, Wisconsin
University of Wisconsin School of Medecine and Public Health
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Study Director: Melody LeBeau Medtronic - MITG
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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT03495154    
Other Study ID Numbers: MDT17051PDS
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal