Accuracy of Robotically Assisted Cranial Biopsies

NCT05891002 | Terminated Results

• 1 other identifier: Angers-Cirq Cranial-01
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Neoplasm

Outcome Measures

Primary Outcomes (1)

• Diagnostic Yield

  Determine the percentage of patients with definitive pathological finding (histologically determined)

  Until study termination, approx. 21 months

Secondary Outcomes (2)

• Target Point and Entry Point Error

  Until study termination, approx. 21 months

• Time for Procedure

  Intraoperative, up to 3 hours

Study Arms (1)

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

Interventions

Cirq® Robotic Alignment Module Cranial DEVICE

Robotic navigation for cranial biopsy procedure

Biopsy Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brainlab AG: lead

Study Sites (1)

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

Angers, 49933, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Prof. Jean-Michel Lemee
• Organization: Centre Hospitalier Univeristaire D'Angers

jmlemee@chu-angers.fr

02.41.35.38.93

Study Officials

• Jean-Michel Lemée, MD

  University Hospital, Angers

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 6, 2023
• Study Start: November 1, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2026-05

Locations

FR (1)