Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT05013333
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2021-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AED 3 Post-Approval Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-10-13', 'mcpReleaseN': 6, 'releaseDate': '2025-09-24'}, {'resetDate': '2025-11-14', 'releaseDate': '2025-10-31'}], 'estimatedResultsFirstSubmitDate': '2025-09-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058687', 'term': 'Out-of-Hospital Cardiac Arrest'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2021-08-16', 'studyFirstSubmitQcDate': '2021-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CPR sensor placement', 'timeFrame': 'Procedure (At time of device placement)', 'description': 'Rate of appropriate placement of the CPR electrodes and compression sensor'}, {'measure': 'Selection of adult or pediatric mode', 'timeFrame': 'Procedure (At time of device placement)', 'description': 'Rate of appropriate selection of child mode by pressing "Child Mode" button or adult mode by not pressing "Child Mode" button determined by energy level of first shock'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiac Arrest, Out-Of-Hospital']}, 'descriptionModule': {'briefSummary': 'Demonstrate appropriate CPR sensor placement on pediatric and adult patients and demonstrate delivery of appropriate energy level of shocks to pediatric and adult patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspected out-of-hospital cardiac arrest\n* Use of ZOLL AED 3 public-access defibrillator (running software v.1.03.602 or newer (US) or v. 6.03.006 or newer(OUS)) with Uni-padz III\n* Unconsciousness\n* Absence of breathing\n* Absence of pulse and other signs of circulation\n\nExclusion Criteria:\n\n* Pre-existing Do Not Attempt Resuscitation (DNAR) orders\n* No evidence of cardiac arrest'}, 'identificationModule': {'nctId': 'NCT05013333', 'briefTitle': 'AED 3 Post-Approval Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Post-Approval Study for AED 3 With Uni-padz', 'orgStudyIdInfo': {'id': '47701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AED 3 with Uni-padz', 'interventionNames': ['Device: AED 3 with Uni-padz']}], 'interventions': [{'name': 'AED 3 with Uni-padz', 'type': 'DEVICE', 'description': 'Use of AED 3 with Uni-padz by lay rescuer', 'armGroupLabels': ['AED 3 with Uni-padz']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '12110', 'city': 'Latham', 'state': 'New York', 'country': 'United States', 'facility': 'Colonie EMS', 'geoPoint': {'lat': 42.74702, 'lon': -73.75901}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}