Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff
- Ability to consent to the procedure
Exclusion Criteria:
- Pregnancy
- Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent