Prospective, multi center, single arm, clinical study to obtain clinical experience with the use of SERI® Surgical Scaffold for soft tissue support in ventral hernia repair.
Prospective, multicenter, single-arm, post-market on-label clinical study of a 510(k)-cleared device. Subjects will be followed for 24 months post SERI placement during index hernia repair surgery. Study visits will occur at screening, from SERI implantation through hospital discharge and then post SERI implantation at month(s) 1, 3, 6, 12, 18, and 24 for all enrolled subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
University of Kentucky
Lexington, Kentucky, United States
Rate of Hernia Recurrence
Hernia recurrence at 6 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Time frame: 6 months postoperatively
Rate of Hernia Recurrence
Hernia recurrence at 12 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Time frame: 12 months postoperatively
Rate of Hernia Recurrence
Hernia recurrence at 24 months post-operatively will be assessed by the Investigator and then confirmed via an independent physician.
Time frame: 24 months postoperatively
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