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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05891002
Study type Observational
Source Brainlab AG
Contact Christine M Bayer, PhD
Phone +49 89 99 15 68
Email christine.bayer@brainlab.com
Status Not yet recruiting
Phase
Start date July 1, 2023
Completion date December 30, 2024

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