This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial. The goal is to determine whether the robotic procedure to be examined can achieve a clinically acceptable value of at least 90% in terms of diagnostic yield.
The goals of the project are to determine the accuracy of Cirq® Robotic Alignment Module Cranial navigated biopsy procedures, Automatic Image Registration accuracy within the workflow, and compatibility of Cirq® Robotic Alignment Module Cranial in the clinical workflow. Patients will undergo cranial biopsies according to standard of care using released products within their intended use with the exception that the accuracy of the biopsy needle will be measured using a specific intraoperative workflow.
Study Type
OBSERVATIONAL
Enrollment
50
Robotic navigation for cranial biopsy procedure
The Centre Hospitalier Universitaire (CHU) d'Angers health establishment
Angers, France
RECRUITINGDiagnostic yield
Determine the percentage of diagnostically significant biopsies determined histologically
Time frame: 24 months
Target point and entry point error
Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location
Time frame: 24 months
Time for procedure
Determine the time needed for the intraoperative biopsy procedure
Time frame: 24 months
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