Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-14 @ 11:40 PM
Study NCT ID:
NCT02008305
Status:
TERMINATED
Last Update Posted:
2017-02-09
First Post:
2013-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-08', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2017-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'number of interrupted dosing', 'timeFrame': 'one day per patient'}], 'primaryOutcomes': [{'measure': 'Comparison of the average dose per child, according to the protocol', 'timeFrame': 'maximum one day per patient'}], 'secondaryOutcomes': [{'measure': 'number of X-rays photographs according to the protocol, quality of photographs according to the protocol,', 'timeFrame': 'maximum one day per patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Occlusion or Malformation of a Cerebral Vessel']}, 'descriptionModule': {'briefSummary': "Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.\n\nThe manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).\n\nChildren are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.\n\nThe investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology\n\nExclusion Criteria:\n\n* opposition ot the parent(s) to the participation of their child in the trial and/or no social security.'}, 'identificationModule': {'nctId': 'NCT02008305', 'acronym': 'MINIRAD', 'briefTitle': 'Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology', 'organization': {'class': 'NETWORK', 'fullName': 'Fondation Ophtalmologique Adolphe de Rothschild'}, 'officialTitle': 'Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology', 'orgStudyIdInfo': {'id': 'SC/DM_MPN_2012-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'protocol of optimization ALARA', 'description': 'protocol of optimization ALARA protocol of optimization of doses', 'interventionNames': ['Device: protocol of optimization ALARA']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'protocol of opimization Philips', 'description': 'protocol of optimization Philips usual protocol of optimization of doses', 'interventionNames': ['Device: protocol of optimization Philips']}], 'interventions': [{'name': 'protocol of optimization ALARA', 'type': 'DEVICE', 'armGroupLabels': ['protocol of optimization ALARA']}, {'name': 'protocol of optimization Philips', 'type': 'DEVICE', 'armGroupLabels': ['protocol of opimization Philips']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Fondation ophtalmique Adolphe de Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Michel Piotin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Ophtalmologique Adolphe de Rothschild'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Ophtalmologique Adolphe de Rothschild', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}