PPDS: Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
Study Details
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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)
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Incidence of hernia recurrence within 12 months following Parietene™ DS Composite Mesh use in ventral hernia repair [12 months post surgery]
Hernia recurrence
Secondary Outcome Measures
- - 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 [operation, 1 month,3 months, 12 months, 24 months post surgery]
adverse device effects (ADEs) and procedure related adverse events
- - Incidence of hernia recurrence at 1, 3 and 24 months. The evaluation of hernia recurrence will be performed during a physical examination [1 month, 3 months, 24 months post surgery]
Hernia recurrence
- - Time to hernia recurrence [up to 2 years post surgery]
- Time to hernia recurrence (from surgery timepoint)
- - Carolinas Comfort Scale™ Quality of life questionnaire completed pre-operatively and at 1, 12 and 24 months postoperatively [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.
- - Time to adverse device effect occurence [up to 2 years post surgery]
-Time to adverse device effect occurrence (from surgery timepoint)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Preoperative Inclusion Criteria
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Subject has provided informed consent
-
Subject is ≥18 years of age (at the time of consent)
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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
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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
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The subject has participated in another investigational drug or device research study within 30 days of enrollment
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
| 2 | Our Lady of the Lakes Regional Medical Center | Baton Rouge | Louisiana | United States | 70808 |
| 3 | University of Missouri - Columbia | Columbia | Missouri | United States | 65201 |
| 4 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 5 | Hernia Center of Excellence Llc | Newport News | Virginia | United States | 23606 |
| 6 | University of Wisconsin School of Medecine and Public Health | Madison | Wisconsin | United States | 53792 |
| 7 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Medtronic - MITG
Investigators
- Study Director: Sue Kim, Medtronic - Surgical Innovations
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT17051PDS