The objective of this clinical investigation is to determine the performance and safety profile of NU-MAX® when used as a topical hemostat for oozing bleedings encountered during intracranial procedures, in which control of bleeding by conventional hemostatic techniques is either ineffective or impractical.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Topical Hemostat
Antwerp University Hospital (UZA)
Edegem, Belgium
% of bleedings reaching hemostasis within 3 minutes
The percentage of bleedings reaching hemostasis within 3 minutes will be measured intraoperatively after the use of NU-MAX® (with a maximum of 3 measurements of hemostasis by NU-MAX® application per subject).
Time frame: Intraoperatively
% of bleedings reaching hemostasis within 6 minutes
The percentage of bleedings reaching hemostasis within 6 minutes will be measured intraoperatively after the use of NU-MAX® (up to 3 measurements per subject).
Time frame: Intraoperatively
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