This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.
Study Type
OBSERVATIONAL
Enrollment
85
Riga East Clinical University Hospital
Riga, Latvia
RECRUITINGRate of Central Nervous System (CNS) Infection
Percentage of subjects with central nervous system infection up to 30 days post-operation, including bacterial meningitis, aseptic meningitis, and/or surgical site infection.
Time frame: Up to 30 days post-operation
Cerebrospinal Fluid (CSF) Leak Rate
Percentage of subjects with cerebrospinal fluid leak after primary dural repair using the Immiseal™ Dural Sealant System, used to assess effective watertight dural closure.
Time frame: Up to 100 ± 10 days post-operation
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