Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-05 @ 1:05 PM
Study NCT ID:
NCT03634657
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2018-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-18', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operator dose', 'timeFrame': 'Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).', 'description': 'Dose of radiation measured'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Scattered radiation', 'X-ray protection', 'Radiation in cath lab'], 'conditions': ['Exposure of Member of Staff to Medical Diagnostic X-Ray']}, 'referencesModule': {'references': [{'pmid': '32338611', 'type': 'DERIVED', 'citation': 'Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing scattered radiation in radial intervention: the ESPRESSO randomised trial. EuroIntervention. 2020 Oct 23;16(8):663-671. doi: 10.4244/EIJ-D-19-00945.'}, {'pmid': '31272982', 'type': 'DERIVED', 'citation': 'Anadol R, Brandt M, Merz N, Knorr M, Ahoopai M, Geyer M, Krompiec D, Wenzel P, Munzel T, Gori T. Effectiveness of additional X-ray protection devices in reducing Scattered radiation in radial interventions: protocol of the ESPRESSO randomised trial. BMJ Open. 2019 Jul 3;9(7):e029509. doi: 10.1136/bmjopen-2019-029509.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for coronary angiography\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03634657', 'acronym': 'ESPRESSO', 'briefTitle': 'EffectivenesS of Additional X-ray PRotection dEviceS in Reducing Scattered Radiation in Radial interventiOn', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor', 'orgStudyIdInfo': {'id': 'ESPRESSO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plain X-ray protection shield', 'interventionNames': ['Radiation: Plain X-ray protection shield']}, {'type': 'EXPERIMENTAL', 'label': 'Protection shield & X-ray protective strips', 'interventionNames': ['Radiation: Protection shield & X-ray protective strips']}, {'type': 'EXPERIMENTAL', 'label': 'Protection shield & protective strips & patient cut-outs', 'interventionNames': ['Radiation: Protection shield & protective strips & patient cut-outs']}], 'interventions': [{'name': 'Plain X-ray protection shield', 'type': 'RADIATION', 'description': 'Coronary angiography with mere X-ray protection shield', 'armGroupLabels': ['Plain X-ray protection shield']}, {'name': 'Protection shield & X-ray protective strips', 'type': 'RADIATION', 'description': 'Coronary angiography with X-ray protection shield \\& X-ray protective strips', 'armGroupLabels': ['Protection shield & X-ray protective strips']}, {'name': 'Protection shield & protective strips & patient cut-outs', 'type': 'RADIATION', 'description': 'Coronary angiography with X-ray protection shield \\& X-ray protective strips \\& X-ray protection patient cut-outs', 'armGroupLabels': ['Protection shield & protective strips & patient cut-outs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'University Medical Center Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tommaso Gori', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiac Catheterization Laboratory ; Director, Study center of Center for Cardiology, university hospital Mainz', 'investigatorFullName': 'Tommaso Gori', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}