Accuracy of Robotically Assisted Cranial Biopsies

Recruiting

• Conditions: Intracranial Neoplasm
• Interventions: Device: Cirq® Robotic Alignment Module Cranial

• Registration Number: NCT05891002
• Lead Sponsor: Brainlab AG

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.

Study Timeline

• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-06
• Study Start: 2023-11-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-10-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biopsy Patient	Cirq® Robotic Alignment Module Cranial	Patient with a confirmed intracranial neoplasm scheduled for a biopsy with Cirq® Robotic Alignment Module Cranial and registration via Auto-Registration Software Universal Automatic Image Registration Cranial and Loop-X® Mobile Imaging Robot.

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	24 months	Determine the percentage of diagnostically significant biopsies determined histologically

Secondary Outcome Measures

Name	Time	Method
Time for procedure	24 months	Determine the time needed for the intraoperative biopsy procedure
Target point and entry point error	24 months	Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location

Trial Locations

Locations (1)

The Centre Hospitalier Universitaire (CHU) d'Angers health establishment; 🇫🇷 Angers, France