Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06934005
Status:
COMPLETED
Last Update Posted:
2025-04-18
First Post:
2025-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-19'}], 'estimatedResultsFirstSubmitDate': '2025-12-19'}}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-16', 'size': 376928, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-10T06:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Following a cross-over design in Part I of the study, two of the four initial Baseplates, is tested for longer wear time (35 days) in this Part II of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-10', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-04-10', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trans epidermal water loss (TEWL) to measure skin-friendliness', 'timeFrame': '35 days', 'description': 'To evaluate the skin barrier functionality (i.e., skin-friendliness) after repeated use of Baseplates (i.e., adhesives) on the skin behind the ear.\n\nHigh levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.High levels of TEWL equates to unhealthy skin = high loss of water that passes from inside a body through the epidermis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical investigation is to test the safety and performance of one short- and one long-term Baseplate constructed with different types of biocompatible adhesives.', 'detailedDescription': 'This clinical investigation intended to test different biocompatible adhesives over time as part of the UNEEG Episight Baseplate construction for UNEEG™ medical A/S.\n\nThe two Baseplates reported on in this registration, is a follow-up to an initial testing of four different types of adhesive i.e., four types of Baseplates.\n\nThis study is Part II of the protocol. Part I is registered: NCT05111847'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained, and letter of authority signed before any study related activities\n* Are at least 18 years of age and have full legal capacity\n* Healthy skin behind the ear\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Known allergic responses to the adhesives\n* Treatment with corticosteroids, either as a cream in the area behind the ear or systemically (tablet or injection) within the last month\n* Subject is unable or does not have the necessary assistance to properly operate the device system'}, 'identificationModule': {'nctId': 'NCT06934005', 'briefTitle': 'Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II', 'organization': {'class': 'INDUSTRY', 'fullName': 'UNEEG Medical A/S'}, 'officialTitle': 'Safety and Performance of Short- and Long-term Baseplates for Attaching the UNEEG Episight Recorder - Part II', 'orgStudyIdInfo': {'id': 'U009 Part II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Short-term Baseplate A and long-term Baseplate C, concomitant use', 'description': 'All participants wore Short-term Baseplate A behind one are and long-term Baseplate C behind the other ear for 35 days.', 'interventionNames': ['Device: Baseplate type A', 'Device: Baseplate type C']}], 'interventions': [{'name': 'Baseplate type A', 'type': 'DEVICE', 'description': 'Type A: Acrylate tested for 35 days behind one ear', 'armGroupLabels': ['Short-term Baseplate A and long-term Baseplate C, concomitant use']}, {'name': 'Baseplate type C', 'type': 'DEVICE', 'description': 'Type C: Hydrocolloid tested for 35 days behind the other ear', 'armGroupLabels': ['Short-term Baseplate A and long-term Baseplate C, concomitant use']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'København NV', 'country': 'Denmark', 'facility': 'Dermato-Venerologisk Afdeling og Videncenter for Sårheling, Bispebjerg Hospital', 'geoPoint': {'lat': 55.71258, 'lon': 12.52343}}], 'overallOfficials': [{'name': 'Tonny Karlsmark, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNEEG Medical A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}