Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-04 @ 3:41 AM
Study NCT ID:
NCT01995357
Status:
COMPLETED
Last Update Posted:
2015-02-03
First Post:
2013-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Influence of Baseplate Adhesive on the Degree of Leakage
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkbir@coloplast.com', 'phone': '+45 4911 1395', 'title': 'MD, Medical Director', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Test A + Training Test A: Pooled data of Test A during part 1 and 2 of the study. Test B + Training Test B: Pooled data of Test B during part 1 and 2 of the study. Standard Care: Data from part 1 of the study only. No Adverse Events on SenSura.', 'eventGroups': [{'id': 'EG000', 'title': 'Test A + Training Test A', 'description': 'Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.\n\nConsequently, Test Product A is used for two periods compared to Standard care which has been used for only one.', 'otherNumAtRisk': 22, 'otherNumAffected': 8, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Test B + Training Test B', 'description': 'Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.\n\nConsequently, Test Product B is used for two periods compared to Standard care which has been used for only one.', 'otherNumAtRisk': 22, 'otherNumAffected': 9, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard Care', 'description': 'Standard care was used only during part one of the study. i.e. for one period only.', 'otherNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Peristomal skin irritation/broken skin/stomal bleeding', 'notes': 'Definitely, probably or possibly related to the product. Causality not defined for 2 events with Test B + Training Test B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold or influenza', 'notes': 'Not related to the product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Planned operation, non-study related', 'notes': 'Not related to the product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herpes Zoster', 'notes': 'Not related to the product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea or constipation', 'notes': 'Not related to the product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain, leg', 'notes': 'Not related to the product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Leakage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '5', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostomy ,Test A'}, {'id': 'OG001', 'title': 'Colostomy, Training + Test A'}, {'id': 'OG002', 'title': 'Colostomy, Test B'}, {'id': 'OG003', 'title': 'Colostomy, Training + Test B'}, {'id': 'OG004', 'title': 'Colostomy, Standard Care (SenSura Mio)'}, {'id': 'OG005', 'title': 'Colostomy, Standard Care (SenSura)'}, {'id': 'OG006', 'title': 'Ileostomy, Test A'}, {'id': 'OG007', 'title': 'Ileostomy, Training + Test A'}, {'id': 'OG008', 'title': 'Ileostomy, Test B'}, {'id': 'OG009', 'title': 'Ileostomy, Training + Test B'}, {'id': 'OG010', 'title': 'Ileostomy, Standard Care (SenSura)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '5.5', 'spread': '5.5', 'groupId': 'OG002'}, {'value': '4.8', 'spread': '5.1', 'groupId': 'OG003'}, {'value': '3.7', 'spread': '6.5', 'groupId': 'OG004'}, {'value': '3.3', 'spread': '3.2', 'groupId': 'OG005'}, {'value': '9.1', 'spread': '5.2', 'groupId': 'OG006'}, {'value': '9.7', 'spread': '5.7', 'groupId': 'OG007'}, {'value': '11.5', 'spread': '5.3', 'groupId': 'OG008'}, {'value': '12.9', 'spread': '5.6', 'groupId': 'OG009'}, {'value': '8.5', 'spread': '5.1', 'groupId': 'OG010'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 (- 2 days)', 'description': 'The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).\n\nResults are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First Coloplast Teast A; Then Coloplast Test B', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B\n\nColoplast Test A: Coloplast Test A is a newly developed ostomy appliance\n\nColoplast Test B: Coloplast Test B is a newly developed ostomy appliance.\n\nStandard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.'}, {'id': 'FG001', 'title': 'First Coloplast Test A; Then Standard Product', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B\n\nColoplast Test A: Coloplast Test A is a newly developed ostomy appliance\n\nColoplast Test B: Coloplast Test B is a newly developed ostomy appliance.\n\nStandard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.'}, {'id': 'FG002', 'title': 'First Coloplast Test B; Then Colopast Test A', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A\n\nColoplast Test A: Coloplast Test A is a newly developed ostomy appliance\n\nColoplast Test B: Coloplast Test B is a newly developed ostomy appliance.\n\nStandard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.'}, {'id': 'FG003', 'title': 'First Coloplast Test B; Then Standard Product', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A\n\nColoplast Test A: Coloplast Test A is a newly developed ostomy appliance\n\nColoplast Test B: Coloplast Test B is a newly developed ostomy appliance.\n\nStandard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.'}, {'id': 'FG004', 'title': 'First Standard Product; Then Coloplast Test A', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nStandard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B\n\nColoplast Test A: Coloplast Test A is a newly developed ostomy appliance\n\nColoplast Test B: Coloplast Test B is a newly developed ostomy appliance.\n\nStandard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.'}, {'id': 'FG005', 'title': 'First Standard Product, Then Coloplast Test B', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nStandard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A\n\nColoplast Test A: Coloplast Test A is a newly developed ostomy appliance\n\nColoplast Test B: Coloplast Test B is a newly developed ostomy appliance.\n\nStandard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'comment': 'The subject who did not complete period 5, erroneously used product A when B should have been used.', 'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 5', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The two discontinued subjects tested zero planned B products in period 5.', 'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'comment': '1 subject terminated due to an adverse event. Subject counted as completed as some B products tested', 'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'Baseline data is summarized for all subjects'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.0', 'spread': '10.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-02', 'studyFirstSubmitDate': '2013-11-21', 'resultsFirstSubmitDate': '2015-01-19', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-02', 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Leakage', 'timeFrame': '10 (- 2 days)', 'description': 'The primary endpoint was the degree of leakage under the baseplate, which was assessed using the three innermost rings of the 32-point leakage scale, corresponding to a total of 24 points (0 indicating no leakage and 24 indicating maximum leakage).\n\nResults are given separately for subjects with colostomy and ileostomy. In the ileostomy group there were no SenSura Mio participants in the standard care group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colostomy Stoma', 'Ileostomy Stoma']}, 'descriptionModule': {'briefSummary': 'The influence of the baseplate adhesive type, shape and application is investigated with regard to the degree of leakage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written informed consent and signed letter of authority\n2. Be at least 18 years of age and have full legal capacity\n3. Have had their ileostomy/colostomy for at least 3 months\n4. Have a stoma with a diameter between 15 and 36 mm\n5. Be able to handle the products themselves\n6. Be able to use a custom cut product\n7. Normally experience faeces under the base plate at least 3 times during 2 weeks\n8. Currently using SenSura 1-piece flat, open or closed bag, pre-cut or custom-cut or SenSura Mio 1-piece flat, closed bag, pre-cut or custom cut\n9. Be willing to test the test products without using paste and/or ring\n10. Be willing to use minimum 1 test product every second day, i.e. maximum 48 hours wear time per prod-uct\n11. Be suitable for participation in the investigation\n12. Be able to present a negative result of a pregnancy test - for women of childbearing age\n\nExclusion Criteria:\n\n1. Are currently receiving or have within the past 2 months received radio- and/or chemotherapy\n2. Are currently receiving or have within the past month received local or systemic steroid treatment in the peristomal area\n3. Are pregnant or breastfeeding\n4. Are participating in other interventional clinical investigations or have previously participated in this investigation\n5. Use irrigation during the investigation (flush the intestines with water)\n6. Are currently suffering from peristomal skin problems, i.e. bleeding and/or broken skin (assessed by the investigator/investigator representative)\n7. Have a loop stoma\n8. Have known hypersensitivity towards any of the test products (including adhesive remover)'}, 'identificationModule': {'nctId': 'NCT01995357', 'briefTitle': 'The Influence of Baseplate Adhesive on the Degree of Leakage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'The Influence of Base Plate Adhesive Type, Shape and Application on Degree of Leak-age - a Randomized Controlled Trial in Subjects With Ileostomy and Colostomy', 'orgStudyIdInfo': {'id': 'CP244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First Coloplast Teast A; then Coloplast Test B', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Standard product']}, {'type': 'EXPERIMENTAL', 'label': 'First Coloplast Test A; Then Standard product', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Standard product']}, {'type': 'EXPERIMENTAL', 'label': 'First Coloplast Test B; Then Colopast Test A', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Standard product']}, {'type': 'EXPERIMENTAL', 'label': 'First Coloplast Test B; Then Standard product', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nColoplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Standard product']}, {'type': 'EXPERIMENTAL', 'label': 'First Standard product; Then Coloplast Test A', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nStandard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Standard product']}, {'type': 'EXPERIMENTAL', 'label': 'First Standard Product, Then Coloplast test B', 'description': 'There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.\n\nThe test sequence in this arm is:\n\nStandard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A', 'interventionNames': ['Device: Coloplast Test A', 'Device: Coloplast Test B', 'Device: Standard product']}], 'interventions': [{'name': 'Coloplast Test A', 'type': 'DEVICE', 'description': 'Coloplast Test A is a newly developed ostomy appliance', 'armGroupLabels': ['First Coloplast Teast A; then Coloplast Test B', 'First Coloplast Test A; Then Standard product', 'First Coloplast Test B; Then Colopast Test A', 'First Coloplast Test B; Then Standard product', 'First Standard Product, Then Coloplast test B', 'First Standard product; Then Coloplast Test A']}, {'name': 'Coloplast Test B', 'type': 'DEVICE', 'description': 'Coloplast Test B is a newly developed ostomy appliance.', 'armGroupLabels': ['First Coloplast Teast A; then Coloplast Test B', 'First Coloplast Test A; Then Standard product', 'First Coloplast Test B; Then Colopast Test A', 'First Coloplast Test B; Then Standard product', 'First Standard Product, Then Coloplast test B', 'First Standard product; Then Coloplast Test A']}, {'name': 'Standard product', 'type': 'DEVICE', 'description': 'Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.', 'armGroupLabels': ['First Coloplast Teast A; then Coloplast Test B', 'First Coloplast Test A; Then Standard product', 'First Coloplast Test B; Then Colopast Test A', 'First Coloplast Test B; Then Standard product', 'First Standard Product, Then Coloplast test B', 'First Standard product; Then Coloplast Test A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Birte P Jakobsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}