Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-28 @ 3:47 AM
Study NCT ID:
NCT02626260
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Evaluation of Adhesives and How They Are Impacted by Output (Round 1b)
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': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-21', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remaining adhesive area of adhesive', 'timeFrame': '30 hours', 'description': 'The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileostomy']}, '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': 'NCT02626260', 'briefTitle': 'A Pilot Evaluation of Adhesives and How They Are Impacted by Output (Round 1b)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Pilot Evaluation of Adhesives and How They Are Impacted by Output', 'orgStudyIdInfo': {'id': 'CP265_01b'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1b', 'description': 'The subject test one adhesive strip on the peristomal area', 'interventionNames': ['Other: adhesive strip']}], 'interventions': [{'name': 'adhesive strip', 'type': 'OTHER', 'description': 'Adhesive strip with a standard adhesive base', 'armGroupLabels': ['Cohort 1b']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}