Craniotomy
Conditions
Brief summary
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.
Interventions
DEVICEClamp-like system
Craniotomy closure
DEVICEPlates and screws
Craniotomy closure
Sponsors
NEOS Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject is 18 years or older. * The subject can be implanted with the assigned craniotomy closure system according to its Instructions for Use. * At least one post-operative medical image (CT scan or Magnetic Resonance image) is planned to be performed. * Life expectancy higher than 6 months. * The subject is willing to give his/her informed consent and to comply with the required follow-up.
Exclusion criteria
* The subject presents any of the contraindications of the assigned craniotomy closure system. * Orbitozygomatic or mastoid craniotomies. * Posterior fossa (skull base) surgeries. * Combined used of craniotomy systems (plates and clamps). * The subject is currently participating in an investigational drug or device study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone flap alignment score | 6 months | 1-4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone-flap alignment score | 0-7 days after surgery (before discharge) | 1-4 |
| Surgeon usability questionnaire | 0 days after surgery | Likert scale \[1-7\], where 1 is very difficult and 7 very easy |
| Frequency of adverse effects and device deficiencies (device safety) | 6 months | Frequency and type of Device related Adverse effects (AE and SAE) and device deficiencies |
| Device-related bulges or visible offsets | 6 months | frequency |
| Post-craniotomy headache | 6 months | Incidence |
| Device related artefacts in neuroimaging | 6 months | frequency |
Countries
Slovenia, Spain
Outcome results
None listed