C69-C72 D32 D33 I60 I61 I62 I67.5 Q28.2 D18.1
Conditions
Interventions
Group 1: Single-arm study: The participation of the subjects and the total duration of treatment relevant for the study is limited to the respective surgery due to the underlying intracranial patholog
Sponsors
Brainlab AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with intracranial pathologies with the indication for navigated neurosurgical intervention where the use of a suction device is required (e.g., resection or open biopsy surgery) - Age = 18 years - Patients are able to provide written informed consent
Exclusion criteria
Exclusion criteria: - Cranial surgeries without the need for neuronavigation - Age < 18 years - Patients are unable to give informed consent - Pregnant or nursing women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of pointing functionality: quantitative assessment of the target registration error (TRE). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Clinical accuracy: qualitative assessment of the appropriateness of navigation accuracy for the indication; • Suctioning capability: o Qualitative assessment of the appropriateness of suctioning capability for the indication; o Quantitative assessment of suctioning capability (count the number of times the Disposable Pre-calibrated Suction needed to be changed to a conventional suction); o Qualitative assessment of the capability of the Disposable Pre-calibrated Suction to stop when intended; • Safety parameters: o Qualitative assessment of the line of sight issues; o Quantitative assessment of complication rate and adverse events (count the number of complications and adverse events); o Quantitative assessment of workflow adaptions needed; Quantitative assessment of pointing/navigation accuracy (count the number of switches to a conventional navigation pointer). | — |
Countries
Germany
Contacts
Public ContactConstantin Roder
Universitätsklinikum Tübingen
Outcome results
None listed