NCT05891002

Accuracy of Robotically Assisted Cranial Biopsies

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Brainlab AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Neoplasm

Interventions

Type	Name	Description
DEVICE	Cirq® Robotic Alignment Module Cranial	Robotic navigation for cranial biopsy procedure

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-10-31
• Completion: 2026-06-30
• First posted: 2023-06-06
• Last updated: 2024-12-13

Locations

1 site across 1 country: France