RecruitingNCT05891002

Accuracy of Robotically Assisted Cranial Biopsies

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


Sponsor

Brainlab AG

Enrollment

50 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria2

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

Interventions

DEVICECirq® Robotic Alignment Module Cranial

Robotic navigation for cranial biopsy procedure


Locations(1)

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

Angers, France

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NCT05891002


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