Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-13 @ 12:57 PM
Study NCT ID:
NCT02886403
Status:
COMPLETED
Last Update Posted:
2016-09-01
First Post:
2016-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Influence of Output on a Newly Develop Adhesive
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': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-31', 'studyFirstSubmitDate': '2016-08-29', 'studyFirstSubmitQcDate': '2016-08-31', 'lastUpdatePostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peel force used to removed the adhesive from the skin', 'timeFrame': '12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'The study investigates the impact real output has on the adhesion of adhesives.'}, '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 an ileostomy for more than one year\n4. Have intact skin on the area used in the evaluation\n5. Has an ileostomy 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. Participating in other interventional clinical investigations or have previously participated in this evaluation'}, 'identificationModule': {'nctId': 'NCT02886403', 'briefTitle': 'Evaluation of the Influence of Output on a Newly Develop Adhesive', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'orgStudyIdInfo': {'id': 'CP265_02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 02', 'description': 'This is a sub-study testing how the adhesion of two adhesives is influenced by exposure to real output.\n\nThere are two visits:\n\nThe first visit:\n\nTwo adhesive strips (standard adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.\n\nThe second visit:\n\nTwo adhesive strips (new adhesive strip) are applied to the peristomal skin and one of these strips is exposed to real output (contained in a sleeve) and the other strip is not.', 'interventionNames': ['Other: Standard adhesive strip', 'Other: New adhesive strip']}], 'interventions': [{'name': 'Standard adhesive strip', 'type': 'OTHER', 'description': 'A standard adhesive strip (hydrocolloid)', 'armGroupLabels': ['Cohort 02']}, {'name': 'New adhesive strip', 'type': 'OTHER', 'description': 'A newly developed adhesive strip', 'armGroupLabels': ['Cohort 02']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Lene F Nielsen, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'R&D scientist'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}