Clinical investigation to compare the clinical safety and performance of a clamp-like device for craniotomy closure, with the standard of care system, titanium plates and screws.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
Craniotomy closure
Craniotomy closure
Maribor University Medical Center
Maribor, Slovenia
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario la Paz
Madrid, Spain
Bone flap alignment score
1-4
Time frame: 6 months
Frequency of adverse effects and device deficiencies (device safety)
Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies
Time frame: 6 months
Bone-flap alignment score
1-4
Time frame: 0-7 days after surgery (before discharge)
Surgeon usability questionnaire
Likert scale \[1-7\], where 1 is very difficult and 7 very easy
Time frame: 0 days after surgery
Device related artefacts in neuroimaging
frequency
Time frame: 6 months
Device-related bulges or visible offsets
frequency
Time frame: 6 months
Post-craniotomy headache
Incidence
Time frame: 6 months
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