Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT05891002
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2023-05-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy of Robotically Assisted Cranial Biopsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2023-05-26', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': '24 months', 'description': 'Determine the percentage of diagnostically significant biopsies determined histologically'}], 'secondaryOutcomes': [{'measure': 'Target point and entry point error', 'timeFrame': '24 months', 'description': 'Determine accuracy of biopsy needle by comparing the target and entry point location to the planned location'}, {'measure': 'Time for procedure', 'timeFrame': '24 months', 'description': 'Determine the time needed for the intraoperative biopsy procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intracranial Neoplasm']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intracranial lesion and the indication for a diagnostic stereotactic biopsy validated by the neurosurgical staff\n* Ability to consent to the procedure\n\nExclusion Criteria:\n\n* Pregnancy\n* Contraindications on narcosis, operation, CT scan, MRI scan and/or Gadolinium contrast agent'}, 'identificationModule': {'nctId': 'NCT05891002', 'briefTitle': 'Accuracy of Robotically Assisted Cranial Biopsies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brainlab AG'}, 'officialTitle': 'Diagnostic Accuracy of Robotically Assisted Cranial Biopsies Using Cirq Active Cranial and Automatic Image Registration', 'orgStudyIdInfo': {'id': 'Angers-Cirq Cranial-01'}}, 'armsInterventionsModule': {'armGroups': [{'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']}], 'interventions': [{'name': 'Cirq® Robotic Alignment Module Cranial', 'type': 'DEVICE', 'description': 'Robotic navigation for cranial biopsy procedure', 'armGroupLabels': ['Biopsy Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Michel Lemee, MD', 'role': 'CONTACT', 'email': 'jmlemee@chu-angers.fr', 'phone': '+33 698935225'}], 'facility': "The Centre Hospitalier Universitaire (CHU) d'Angers health establishment", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'Christine M Bayer, PhD', 'role': 'CONTACT', 'email': 'christine.bayer@brainlab.com', 'phone': '+49 89 99 15 68', 'phoneExt': '0'}], 'overallOfficials': [{'name': 'Jean-Michel Lemée, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brainlab AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}