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Trial Title:
Accuracy of Robotically Assisted Cranial Biopsies
NCT ID:
NCT05891002
Condition:
Intracranial Neoplasm
Conditions: Official terms:
Brain Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Cirq® Robotic Alignment Module Cranial
Description:
Robotic navigation for cranial biopsy procedure
Arm group label:
Biopsy Patient
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 1, 2023
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Brainlab AG
Agency class:
Industry
Source:
Brainlab AG
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05891002
