Evaluating the accuracy of robotic cranial biopsies
Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration
This study is testing how well a robotic system can perform brain biopsies on patients with brain tumors to see if it can accurately diagnose their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brainlab AG Industry-sponsored |
| Locations | 1 site (Angers) |
| Trial ID | NCT05891002 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the accuracy of the Cirq® Robotic Alignment Module Cranial in performing biopsies on patients with intracranial neoplasms. The study aims to achieve a diagnostic yield of at least 90% by measuring the accuracy of the biopsy needle within a specific intraoperative workflow. Patients will undergo standard care procedures while the robotic system's performance is evaluated in a clinical setting. The study focuses on the compatibility of the robotic system with existing clinical workflows and the accuracy of automatic image registration.
Who should consider this trial
Good fit: Ideal candidates include patients with an intracranial lesion requiring a diagnostic stereotactic biopsy.
Not a fit: Patients who are pregnant or have contraindications to anesthesia, surgery, or imaging procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the precision of cranial biopsies, leading to better diagnostic outcomes for patients with brain tumors.
How similar studies have performed: While this study is focused on a specific robotic system, similar robotic-assisted biopsy approaches have shown promise in improving diagnostic accuracy in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Angers
- The Centre Hospitalier Universitaire (CHU) d'Angers health establishment — Angers, France (Recruiting)
Study contacts
- Study coordinator: Christine M Bayer, PhD
- Email: christine.bayer@brainlab.com
- Phone: +49 89 99 15 68
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.