Post Market Study of Parietene™ DS Composite Mesh in Ventral Hernia Repair
Completed · Not applicable
Conditions studied: Ventral Hernia
In brief
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)
Key facts
- Study ID
- NCT03495154
- Run by
- Medtronic - MITG
- People needed
- 145
- Starts
- 2018-06-21
- Expected to finish
- 2022-07-06
- Last updated by the study team
- 2024-04-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Our Lady of the Lakes Regional Medical Center — Baton Rouge, Louisiana, United States
- University of Missouri - Columbia — Columbia, Missouri, United States
- The Ohio State University — Columbus, Ohio, United States
- Hernia Center of Excellence LLC — Newport News, Virginia, United States
- University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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