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Accuracy of Robotically Assisted Cranial Biopsies

NCT ID: NCT05891002

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Intracranial Neoplasm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cirq® Robotic Alignment Module Cranial

Intervention Type DEVICE

Robotic navigation for cranial biopsy procedure

Interventions

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Cirq® Robotic Alignment Module Cranial

Robotic navigation for cranial biopsy procedure

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brainlab AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Michel Lemée, MD

Role: STUDY_DIRECTOR

University Hospital, Angers

Locations

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

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christine M Bayer, PhD

Role: CONTACT

Phone: +49 89 99 15 68

Email: [email protected]

Facility Contacts

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Jean-Michel Lemee, MD

Role: primary

Other Identifiers

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Angers-Cirq Cranial-01

Identifier Type: -

Identifier Source: org_study_id