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)
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
145
All subjects enrolled will receive the Parietene DS Composite Mesh
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
Number of Participants With Hernia Recurrence Within 12 Months Following Parietene™ DS Composite Mesh Use in Ventral Hernia Repair
Time frame: 12 months post surgery
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.
Time frame: 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
Time frame: 1 month, 3 months, and 24 months post-surgery
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University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States