The clinical study could not be commenced due to the Principal Investigator's limited availability, which has significantly impacted the feasibility of continuing the study as planned. No safety concerns or adverse events were detected.

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.

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

50 consecutive patients who are planned to undergo a brain biopsy will be included. Since this is a confirmatory study, a sample size calculation was not able to be performed.

From enrollment until end of index hospital stay, an average of 1 week.

This prospective study represents a low number of cases. Only 4 out of 50 planned patients were enrolled making it difficult to conduct meaningful analyses that can be applied to the entire patient cohort that is being treated.