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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Ventral Hernia

Intervention / Treatment
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* Device: Parietene DS Composite Mesh


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parietene DS Composite Mesh<br>Patients treated with Parietene DS Composite Mesh | Device: Parietene DS Composite Mesh<br>* All subjects enrolled will receive the Parietene DS Composite Mesh<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair |  | 12 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | operation, discharge, 1 month, 3 months, 12 months and 24 months post surgery | 
| 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 |  | 1 month, 3 months, and 24 months post-surgery | 
| Time to Hernia Recurrence (From Surgery Timepoint) |  | from time of surgery up to 24 months post-surgery | 
| Time to Adverse Device Effect Occurrence (From Surgery Timepoint) |  | from the time of surgery up to 24 months post-surgery | 
| 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. | pre-operatively, 1 month, 12 months and 24 months post-operatively |