RecruitingNCT05891002

Accuracy of Robotically Assisted Cranial Biopsies

Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration


Sponsor

Brainlab AG

Enrollment

50 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a robot-assisted guidance system makes brain biopsies more accurate and safe compared to traditional freehand stereotactic methods, potentially improving diagnostic precision for patients with unknown brain lesions. **You may be eligible if...** - You have a brain lesion that your neurosurgical team has determined needs a diagnostic biopsy - You are able to give informed consent for the procedure and participation in the study **You may NOT be eligible if...** - You are pregnant - You have contraindications to general anesthesia, surgery, CT scanning, MRI, or the contrast dye Gadolinium Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECirq® Robotic Alignment Module Cranial

Robotic navigation for cranial biopsy procedure


Locations(1)

The Centre Hospitalier Universitaire (CHU) d'Angers health establishment

Angers, France

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NCT05891002


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