Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 1:15 AM
Study NCT ID:
NCT03423134
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2018-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Performance of a New Adhesive Strip
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2018-01-31', 'studyFirstSubmitQcDate': '2018-01-31', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'trans epidermal water loss', 'timeFrame': '24 hours', 'description': 'The trans epidermal water loss is a measure for the skins barrier function. There is always a loss of water from the skin due to evaporation. When the skin barrier is damaged the evaporation of water increases. Thus, trans epidermal water loss can be used to assess skin damage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'This study investigates the performance of a new adhesive'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written informed consent\n2. Be at least 18 years of age and have full legal capacity\n3. Have had a stoma for more than one year\n4. Have intact skin on the area used in the evaluation\n5. Has a stoma with a diameter up to (≤) 35 mm\n6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)\n\nExclusion Criteria:\n\n1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy\n2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.\n3. Are pregnant or breastfeeding\n4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)\n5. Actively participating in other interventional clinical investigations or have previously participated in this investigation.\n\n5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)'}, 'identificationModule': {'nctId': 'NCT03423134', 'briefTitle': 'Investigating the Performance of a New Adhesive Strip', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put', 'orgStudyIdInfo': {'id': 'CP265_19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test of new adhesive strip', 'description': 'A new adhesive strip will be tested in this investigation', 'interventionNames': ['Other: New adhesive strip']}], 'interventions': [{'name': 'New adhesive strip', 'type': 'OTHER', 'description': 'This is a strip made of a newly developed adhesive', 'armGroupLabels': ['Test of new adhesive strip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Lene F Nielsen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of the pre-clinical department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}