Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT03139968
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Catheterization Radiation Exposure Pad
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Patient, operator and investigator are blinded to dummy drape vs RADPAD.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 766}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-30', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary operator radiation exposure (mSv)', 'timeFrame': 'immediately post-procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radiation; Exposure Occupational', 'Coronary Interventions']}, 'referencesModule': {'references': [{'pmid': '29089313', 'type': 'DERIVED', 'citation': "Vlastra W, Delewi R, Sjauw KD, Beijk MA, Claessen BE, Streekstra GJ, Bekker RJ, van Hattum JC, Wykrzykowska JJ, Vis MM, Koch KT, de Winter RJ, Piek JJ, Henriques JPS. Efficacy of the RADPAD Protection Drape in Reducing Operators' Radiation Exposure in the Catheterization Laboratory: A Sham-Controlled Randomized Trial. Circ Cardiovasc Interv. 2017 Nov;10(11):e006058. doi: 10.1161/CIRCINTERVENTIONS.117.006058."}]}, 'descriptionModule': {'briefSummary': 'The RECAP-trial is a randomized controlled, double blinded, superiority trial studying the efficacy of the RADPAD®, a protective drape, that potentially reduces the scattered radiation received by the operator during diagnostic angiograms and percutaneous coronary interventions.', 'detailedDescription': 'A total of 750 consecutive diagnostic angiograms and percutaneous coronary interventions were randomly assigned to the radiation-attenuating (RADPAD®), a dummy drape or a control group in a 1:1:1 ratio. The drapes will be used in addition to conventional shielding material. Primary radiation exposure is measured blindly by a dose aware meter (Philips) positioned at a set location on the operator. Radiation exposure is measured by the X-ray systems (DAP in Gy·cm2). The primary outcome is the effective dose received by the first operator (mSv/Gy·cm2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All CAGs and PCI's\n\nExclusion Criteria:\n\n* Other interventional procedures"}, 'identificationModule': {'nctId': 'NCT03139968', 'acronym': 'RECAP', 'briefTitle': 'Reduction of Catheterization Radiation Exposure Pad', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': "Reduction of the Operator's Radiation Exposure During CAG and PCI With RADPAD, a Randomized Controlled Double-blinded Trial", 'orgStudyIdInfo': {'id': 'RECAP-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiation absorbing drape', 'description': 'Conventional protection measurements. Additionally, a lead-free protective, disposable drape containing bismuth and antimony (RADPAD®) is placed onto the sterile drape on the patient between the operator and the image intensifier.', 'interventionNames': ['Device: (sham) radiation absorbing drape (RADPAD®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dummy group', 'description': 'Conventional protection measurements. Additionally, a dummy, silicone, disposable drape (appearing identical to the experimental arm) is placed onto the sterile drape on the patient between the operator and the image intensifier.', 'interventionNames': ['Device: (sham) radiation absorbing drape (RADPAD®)']}, {'type': 'NO_INTERVENTION', 'label': 'Control goup', 'description': 'Only conventional protection measurements.'}], 'interventions': [{'name': '(sham) radiation absorbing drape (RADPAD®)', 'type': 'DEVICE', 'armGroupLabels': ['Dummy group', 'Radiation absorbing drape']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'J.P.S Henriques', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. dr. J.P.S. Henriques', 'investigatorFullName': 'J.P.S Henriques', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}