Intracranial NeoplasmNCT05891002

Accuracy of Robotically Assisted Cranial Biopsies

An observational study of Intracranial Neoplasm, run by Brainlab AG at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intracranial Neoplasm
What is being tested?: Cirq® Robotic Alignment Module Cranial
Type of treatment: Medical device
How many people: 4 participants
Where: 1 siteFrance
Study dates: 1 Nov 2023to 28 Jul 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff
Ability to consent to the procedure

Who cannot join

Pregnancy
Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent

Trial locations and contacts

1 site in 1 country.

France1 site

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

Other trials in France

About this study

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

Read the 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
Being tested: Cirq® Robotic Alignment Module Cranial
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cirq® Robotic Alignment Module CranialDevice
Robotic navigation for cranial biopsy procedure

Study groups in NCT05891002
Study group	Role	What they receive
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. Receives: Device: Cirq® Robotic Alignment Module Cranial

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202328 Jul 2025

First posted6 Jun 2023
Study start1 Nov 2023
Primary completion28 Jul 2025
Study completion28 Jul 2025

Why it stopped: The clinical study could not be commenced due to the Principal Investigator's limited availability, which has significantly impacted the feasibility of continuing the study as planned. No safety concerns or adverse events were detected.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intracranial NeoplasmStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05891002
Sponsor's protocol ID: Angers-Cirq Cranial-01
Status last verified: May 2026
First submitted: 26 May 2023
Last updated: 1 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intracranial Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration
ClinicalTrials.gov ID: NCT05891002
Acronym / sponsor ID: Angers-Cirq Cranial-01
Conditions: Intracranial Neoplasm
Study type: Observational
Recruitment status: TerminatedReason stopped: The clinical study could not be commenced due to the Principal Investigator's limited availability, which has significantly impacted the feasibility of continuing the study as planned. No safety concerns or adverse events were detected.
Enrolment: 4 participants (actual)
Lead sponsor: Brainlab AGIndustry (pharma, biotech, devices)
Study start: 1 Nov 2023 (actual)
Primary completion: 28 Jul 2025 (actual)
Study completion: 28 Jul 2025 (actual)
First posted: 6 Jun 2023 (actual)
Results: Posted 1 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Biopsy Patient	–	Device: Cirq® Robotic Alignment Module CranialPatient 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff
Ability to consent to the procedure

Key exclusion criteria (2 listed)

Pregnancy
Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cirq® Robotic Alignment Module CranialRobotic navigation for cranial biopsy procedure	Device	Biopsy Patient

Primary outcome

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

2 secondary outcomes

Target Point and Entry Point Error
Time frame: Until study termination, approx. 21 months
Time for Procedure
Time frame: Intraoperative, up to 3 hours

Results and safety

Results posted to the registry on 1 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	4	3

Primary outcome: Diagnostic Yield

Time frame: Until study termination, approx. 21 months. Number. Unit: % of pat. with definitive path. finding

Measure	Intervention n = 3
Value	100

Population analysed: 4 patients were enrolled to the intervention group. There was no control group. The primary endpoint was collected from 3/4 patients.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of index hospital stay, an average of 1 week.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): This prospective study represents a low number of cases. Only 4 out of 50 planned patients were enrolled making it difficult to conduct meaningful analyses that can be applied to the entire patient cohort that is being treated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Intracranial Neoplasm

Not yet recruitingPhase 2
The METAMAX Study: MT027 Allogeneic CAR-T for Brain Metastases From Advanced Solid Tumors
Brain Metastases From Solid Tumors
RecruitingObservational study
International PPB/DICER1 Registry
Pleuropulmonary Blastoma, Sertoli-Leydig Cell Tumor
RecruitingPhase 2
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Meningioma
RecruitingPhase 1
Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma
Recurrent Astrocytoma, IDH-Mutant, Grade 3, Recurrent Astrocytoma, IDH-Mutant, Grade 4
Active, not recruitingObservational study
China Treatment Trial for Tumor in Sellar Region With Unruptured Intracranial Aneurysm
Unruptured Intracranial Aneurysms, Pituitary Neuroendocrine Tumor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Michel Lemée, MD study director

University Hospital, Angers

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Neoplasm, run by Brainlab AG at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Yield (time frame: Until study termination, approx. 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05891002.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.