Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-31 @ 4:47 PM
Study NCT ID:
NCT07256951
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gen 2 Battrode Wear Study
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': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wear time', 'timeFrame': '15 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Adhesive Wear Time']}, 'descriptionModule': {'briefSummary': 'Validating adhesive wear time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant is ≥ 18 years.\n2. Completes the consent process as required.\n3. Participants can speak and read English fluently.\n4. Willing to allow shaving of device application area, as required.\n5. Willing to take photos of the application area before wear, daily during wear, and immediately after removal.\n6. Willingness to report current known pregnancy.\n\nExclusion Criteria:\n\n1. Unable to comply with the study protocol and instructions for wearing the devices for up to 15 days.\n2. Any pre-existing breached or compromised skin, skin rash, irritation or infection at the application area.\n3. Any incision, wound or scar in the application area.\n4. Participants with known skin allergies and sensitivities to adhesives.\n5. Participants with scheduled electronic imaging (including magnetic resonance imaging), cardioversion, and/or procedures where device would be removed during the data collection period.\n6. Participants with known history of cardiac arrhythmias.\n7. Participants with chest anatomies not compatible with secure parasternal placement.\n8. Use of clothing or garment that can dislodge or loosen the patch or bras with underwires or other worn items that might interfere with the devices under study.'}, 'identificationModule': {'nctId': 'NCT07256951', 'briefTitle': 'Gen 2 Battrode Wear Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'Gen 2 Battrode Wear Study', 'orgStudyIdInfo': {'id': 'BXU610410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'adhesive one', 'interventionNames': ['Device: Adhesive']}, {'type': 'EXPERIMENTAL', 'label': 'Adhesive two', 'interventionNames': ['Device: Adhesive']}], 'interventions': [{'name': 'Adhesive', 'type': 'DEVICE', 'description': '14 day wear', 'armGroupLabels': ['Adhesive two', 'adhesive one']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Orange County Research Center', 'role': 'CONTACT', 'phone': '7145509990'}], 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}