N/A
N=145
Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
Ventral Hernia
Bottom Line
View on ClinicalTrials.gov: NCT03495154 ↗Enrolled (actual)
145
Serious AEs
23.2%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair — 4; 116 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Parietene DS Composite Mesh (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair |
4; 116 | — |
| SECONDARY 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. |
0; 14; 31; 34; 40; 42 | — |
| SECONDARY 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 |
0; 0; 4 | — |
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)
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
Data sourced from ClinicalTrials.gov (NCT03495154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.