Intracranial Neoplasm
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICECirq® Robotic Alignment Module Cranial
Robotic navigation for cranial biopsy procedure
Sponsors
Brainlab AG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Yield | Until study termination, approx. 21 months | Determine the percentage of patients with definitive pathological finding (histologically determined) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Point and Entry Point Error | Until study termination, approx. 21 months | Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location |
| Time for Procedure | Intraoperative, up to 3 hours | Determine the time needed for the intraoperative biopsy procedure |
Countries
France
Contacts
STUDY_DIRECTORJean-Michel Lemée, MD
University Hospital, Angers
Participant flow
Recruitment details
4 patients could be recruited.
Pre-assignment details
Inclusion and exclusion criteria were reviewed and enrolled patients consented.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71 years |
| Region of Enrollment France | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
None listed