Accuracy of Robotically Assisted Cranial Biopsies

Intracranial Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05891002
• Other study ID #: Angers-Cirq Cranial-01
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Brainlab AG
• Contact: Christine M Bayer, PhD
• Phone: +49 89 99 15 68
• Email: christine.bayer[@]brainlab.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Neoplasm

Intervention

Device:
• Cirq® Robotic Alignment Module Cranial
Robotic navigation for cranial biopsy procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brainlab AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic yield	Determine the percentage of diagnostically significant biopsies determined histologically	24 months
Secondary	Target point and entry point error	Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location	24 months
Secondary	Time for procedure	Determine the time needed for the intraoperative biopsy procedure	24 months