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

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parietene DS Composite Mesh
Sponsored by
Medtronic - MITG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady of the Lakes Regional Medical Center
  • University of Missouri - Columbia
  • The Ohio State University
  • Hernia Center of Excellence LLC
  • University of Wisconsin School of Medicine and Public Health
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parietene DS Composite Mesh

Arm Description

Patients treated with Parietene DS Composite Mesh

Outcomes

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

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
Time to Hernia Recurrence (From Surgery Timepoint)
Time to Adverse Device Effect Occurrence (From Surgery Timepoint)
Carolinas Comfort Scale™ Quality of Life Questionnaire Completed Pre-operatively and at 1 Month,12 Months and 24 Months Post-operatively
The Carolina Comfort Scale is a validated, disease specific, questionnaire developed for participants to assess quality of life pre- and post- hernia repair with mesh. Each question on the questionnaires is scored on a scale of 0-5 with 0 indicating no symptoms and 5 indicating disabling symptoms. The Carolina Comfort Scale measures severity of pain (Min Score: 0, Max Score: 40), sensation of mesh (post-operative assessment only, Min Score: 0, Max Score: 40), and movement limitations (Min Score: 0, Max Score: 35) in the following eight categories: lying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking up stairs, and exercise. An average of the 8 categories is computed at each timepoint for each of the 3 questionnaires with the best possible score of 0 and the worst possible score of 115. A lower score on the questionnaire would indicate a better outcome.

Full Information

First Posted
March 27, 2018
Last Updated
August 14, 2023
Sponsor
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT03495154
Brief Title
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
Acronym
PPDS
Official Title
A Multi-center Post-market Single Arm Prospective Study of Parietene™ DS Composite Mesh in Subjects Undergoing Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2018 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic - MITG

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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)
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
All subjects enrolled will receive the Parietene DS Composite Mesh
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parietene DS Composite Mesh
Arm Type
Experimental
Arm Description
Patients treated with Parietene DS Composite Mesh
Intervention Type
Device
Intervention Name(s)
Parietene DS Composite Mesh
Intervention Description
All subjects enrolled will receive the Parietene DS Composite Mesh
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
Time to Hernia Recurrence (From Surgery Timepoint)
Time Frame
from time of surgery up to 24 months post-surgery
Title
Time to Adverse Device Effect Occurrence (From Surgery Timepoint)
Time Frame
from the time of surgery up to 24 months post-surgery
Title
Carolinas Comfort Scale™ Quality of Life Questionnaire Completed Pre-operatively and at 1 Month,12 Months and 24 Months Post-operatively
Description
The Carolina Comfort Scale is a validated, disease specific, questionnaire developed for participants to assess quality of life pre- and post- hernia repair with mesh. Each question on the questionnaires is scored on a scale of 0-5 with 0 indicating no symptoms and 5 indicating disabling symptoms. The Carolina Comfort Scale measures severity of pain (Min Score: 0, Max Score: 40), sensation of mesh (post-operative assessment only, Min Score: 0, Max Score: 40), and movement limitations (Min Score: 0, Max Score: 35) in the following eight categories: lying down, bending over, sitting up, activities of daily living, coughing or deep breathing, walking up stairs, and exercise. An average of the 8 categories is computed at each timepoint for each of the 3 questionnaires with the best possible score of 0 and the worst possible score of 115. A lower score on the questionnaire would indicate a better outcome.
Time Frame
pre-operatively, 1 month, 12 months and 24 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Kim
Organizational Affiliation
Medtronic - Surgical Innovations
Official's Role
Study Director
Facility Information:
Facility Name
Our Lady of the Lakes Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
University of Missouri - Columbia
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hernia Center of Excellence LLC
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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