Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
- Conditions
- Ventral Hernia
- Interventions
- Device: Parietene DS Composite Mesh
- Registration Number
- NCT03495154
- Lead Sponsor
- 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)
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Parietene DS Composite Mesh Parietene DS Composite Mesh Patients treated with Parietene DS Composite Mesh
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (6)
Our Lady of the Lakes Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
University of Wisconsin School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hernia Center of Excellence LLC
🇺🇸Newport News, Virginia, United States
University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States