Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-02 @ 4:51 AM
Study NCT ID:
NCT04562259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-09-24
First Post:
2020-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Verification of Kimmerle's Anomaly by X-ray Methods of Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In patients with Kimmerle anomaly, determine the types of forms of this pathology', 'timeFrame': 'up to 36 months', 'description': "In patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Kimmerle's Anomaly"]}, 'descriptionModule': {'briefSummary': "Kimmerle's anomaly is a bony bridge over the posterior arch of the first cervical vertebra that forms a bony ring. The vertebral artery passes through the opening. This bone bridge could theoretically be an extravasal compression of the artery and disrupt the normal blood flow to the brain. Evaluating the data of X-ray methods, determine the frequency of occurrence and types of Kimmerle anomaly.", 'detailedDescription': "It is planned to conduct an examination of 30 patients on the basis of the Department of Radiation Diagnostics and Therapy of the Samarkand State Medical Institute. Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region Among those who have passed the study, it is necessary to identify patients with Kimmerle's anomaly and determine the age at which it often occurs, whether it is a congenital pathology or the result of degenerative-dystrophic changes. It is also planned to calculate the frequency of occurrence among the population, the type of this pathology (complete and incomplete bone bridge, right-sided and left-sided location), the size of the hole formed. The condition of the posterior parts of the brain will be assessed in the presence of Kimmerle's anomaly on a CT scan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of all ages will be examined, directed by doctors for computed tomography of the brain with the capture of the upper cervical spine and the cervical spine. with complaints of headache, dizziness, pain in the cervical region', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Kimmerle's anomaly\n\nExclusion Criteria:\n\n* patients in whom the structure of the first cervical vertebra is not clearly visible"}, 'identificationModule': {'nctId': 'NCT04562259', 'briefTitle': "Verification of Kimmerle's Anomaly by X-ray Methods of Research", 'organization': {'class': 'OTHER', 'fullName': 'Samarkand State Medical Institute'}, 'officialTitle': "Verification of Kimmerle's Anomaly by X-ray Methods of Research", 'orgStudyIdInfo': {'id': 'Project#3'}}, 'armsInterventionsModule': {'armGroups': [{'label': "patients with Kimmerle's anomaly", 'description': 'patients who have a complete or incomplete bony bridge over the posterior arch of the first cervical vertebra', 'interventionNames': ["Radiation: Verification of Kimmerle's anomaly by x-ray methods of research"]}], 'interventions': [{'name': "Verification of Kimmerle's anomaly by x-ray methods of research", 'type': 'RADIATION', 'description': "In patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly.", 'armGroupLabels': ["patients with Kimmerle's anomaly"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '140100', 'city': 'Samarkand', 'country': 'Uzbekistan', 'facility': 'Samarkand State Medical Institute', 'geoPoint': {'lat': 39.65456, 'lon': 66.96445}}], 'overallOfficials': [{'name': 'Gulshod Mardieva, docent', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samarkand State Medical Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samarkand State Medical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}