Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT02133261
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2014-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-25', 'studyFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2014-05-06', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adhesive performance/durability', 'timeFrame': '7 days', 'description': "The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2."}], 'secondaryOutcomes': [{'measure': 'human factors', 'timeFrame': '7 days', 'description': 'Skin comfort or discomfort Device comfort Device stability and contact'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Patients', 'ECG Monitoring']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.', 'detailedDescription': 'The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "cardiac patients followed at the study site's location", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cardiac patient volunteers (5 male and 5 female)\n\nExclusion Criteria:\n\n* skin rash or infection over the sternum\n* Sternal incision within 3 months from the date of enrollment'}, 'identificationModule': {'nctId': 'NCT02133261', 'briefTitle': 'BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bardy Diagnostics, Inc.'}, 'officialTitle': 'BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study', 'orgStudyIdInfo': {'id': '7 day study'}}, 'contactsLocationsModule': {'locations': [{'zip': '98022', 'city': 'Enumclaw', 'state': 'Washington', 'country': 'United States', 'facility': 'EvergreenHealth', 'geoPoint': {'lat': 47.20427, 'lon': -121.9915}}], 'overallOfficials': [{'name': 'Gene Trobaugh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'EvergreenHealth'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bardy Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}