Clinical trial · Observational
Accuracy of Robotically Assisted Cranial Biopsies
Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intracranial Neoplasm | Intracranial Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cirq® Robotic Alignment Module Cranial | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biopsy Patient
- description
- 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.
- interventionNames
- Device: Cirq® Robotic Alignment Module Cranial
Primary outcomes (1)
- measure
- Diagnostic Yield
- timeFrame
- Until study termination, approx. 21 months
- description
- Determine the percentage of patients with definitive pathological finding (histologically determined)
Secondary outcomes (2)
- measure
- Target Point and Entry Point Error
- timeFrame
- Until study termination, approx. 21 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available