Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-27 @ 8:03 PM
Study NCT ID:
NCT01590368
Status:
UNKNOWN
Last Update Posted:
2012-05-04
First Post:
2012-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-11-07', 'releaseDate': '2012-10-09'}, {'resetDate': '2013-08-29', 'releaseDate': '2013-07-29'}, {'resetDate': '2013-11-04', 'releaseDate': '2013-09-02'}, {'resetDate': '2014-03-28', 'releaseDate': '2014-02-06'}, {'resetDate': '2017-05-23', 'releaseDate': '2017-04-20'}, {'resetDate': '2018-01-22', 'releaseDate': '2017-12-20'}], 'estimatedResultsFirstSubmitDate': '2012-10-09'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-02', 'studyFirstSubmitDate': '2012-05-01', 'studyFirstSubmitQcDate': '2012-05-01', 'lastUpdatePostDateStruct': {'date': '2012-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Product Performance : Remain in place', 'timeFrame': '30 minutes', 'description': 'Ability to remain in place for a duration of 30 minutes (as per intended use)'}, {'measure': 'Product Performance: Perform', 'timeFrame': '30 minutes', 'description': 'Ability of the electrodes to perform after a duration of 30 minutes of wear (ECG tracing) as per intended use.'}], 'secondaryOutcomes': [{'measure': 'Safety: Adverse Events', 'timeFrame': '2 days', 'description': 'Safety will be evaluated by the nature and frequency of adverse events, (including condition of the skin under the electrodes using the Skin Irritation Scale (Appendix 4)) and ease of removal'}, {'measure': 'Skin Rating', 'timeFrame': '2 days', 'description': 'Condition of the skin under the electrodes using the Skin Irritation Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'It is hypothesised that the adhesion of electrodes and acceptability of the Electrocardiogram (ECG) trace is comparable between the two groups (marketed and test products) after 30 minutes (the intended period of use) of the electrodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent\n* Be a healthy volunteer and be over 18 years of age\n* Willing to attend two scheduled visits for application and removal of the device and adverse event review\n* Have healthy unbroken skin\n\nExclusion Criteria:\n\n* Subjects with a history of sensitivity to any one of the components of the device being studied\n* Subjects who have a history of skin related disorders to the chest.\n* Subjects who are actively involved in the development, manufacturing, quality and marketing of Unomedical electrodes\n* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study\n* Subjects who have any current cardiac conditions that may lead to an abnormal ECG trace'}, 'identificationModule': {'nctId': 'NCT01590368', 'briefTitle': 'A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode', 'organization': {'class': 'INDUSTRY', 'fullName': 'ConvaTec Inc.'}, 'officialTitle': 'A Comparative Wear Test of Two Adhesives on the Unilect ™ Biotab Short Term Monitoring Electrode', 'orgStudyIdInfo': {'id': 'UM-1015-12-U365'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Marketed electrode', 'description': 'The currently marketed electrodes using the current CE marked adhesive', 'interventionNames': ['Device: Marketed electrode']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Modified hydrogel', 'description': 'Electrodes with the new modified adhesive - the "test" electrodes', 'interventionNames': ['Device: Modified "test" electrode']}], 'interventions': [{'name': 'Marketed electrode', 'type': 'DEVICE', 'description': '12 electrodes will be placed on the subject for an ECG reading to be taken', 'armGroupLabels': ['Marketed electrode']}, {'name': 'Modified "test" electrode', 'type': 'DEVICE', 'description': '12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken', 'armGroupLabels': ['Modified hydrogel']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Barbara A Schofield', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Cheshire Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ConvaTec Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-10-09', 'type': 'RELEASE'}, {'date': '2012-11-07', 'type': 'RESET'}, {'date': '2013-07-29', 'type': 'RELEASE'}, {'date': '2013-08-29', 'type': 'RESET'}, {'date': '2013-09-02', 'type': 'RELEASE'}, {'date': '2013-11-04', 'type': 'RESET'}, {'date': '2014-02-06', 'type': 'RELEASE'}, {'date': '2014-03-28', 'type': 'RESET'}, {'date': '2017-04-20', 'type': 'RELEASE'}, {'date': '2017-05-23', 'type': 'RESET'}, {'date': '2017-12-20', 'type': 'RELEASE'}, {'date': '2018-01-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'ConvaTec Inc.'}}}}