Accuracy of Robotically Assisted Cranial Biopsies

Brainlab

Status: Enrolling

Conditions: Intracranial Neoplasm

Treatments: Device: Cirq® Robotic Alignment Module Cranial

Study type: Observational

Funder types: Industry

Identifiers

NCT05891002

Angers-Cirq Cranial-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Biopsy Patient

Description:

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.

Treatment:

Device: Cirq® Robotic Alignment Module Cranial