Accuracy of Robotically Assisted Cranial Biopsies

May 5, 2026 updated by: Brainlab AG

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • The Centre Hospitalier Universitaire (CHU) d'Angers health establishment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

50 consecutive patients who are planned to undergo a brain biopsy will be included. Since this is a confirmatory study, a sample size calculation was not able to be performed.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Biopsy Patient
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.
Device: Cirq® Robotic Alignment Module Cranial
Robotic navigation for cranial biopsy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Yield
Time Frame: Until study termination, approx. 21 months
Determine the percentage of patients with definitive pathological finding (histologically determined)
Until study termination, approx. 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Point and Entry Point Error
Time Frame: Until study termination, approx. 21 months
Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location
Until study termination, approx. 21 months
Time for Procedure
Time Frame: Intraoperative, up to 3 hours
Determine the time needed for the intraoperative biopsy procedure
Intraoperative, up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brainlab AG

Investigators

  • Study Director: Jean-Michel Lemée, MD, University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

July 28, 2025

Study Completion (Actual)

July 28, 2025

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Angers-Cirq Cranial-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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