Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-28 @ 5:11 AM
Study NCT ID:
NCT01103466
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of the Performance of Ostomy Base Plate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dklhp@coloplast.com', 'phone': '4549111111', 'title': 'Dr. Lis Hentze Poulsen', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected from inclusion to the end of the three test periods (~43 days).', 'description': 'The safety population contained 37 subjects, whereof two subjects were excluded from the ITT population due to inclusion criteria violation and did not try any test products.', 'eventGroups': [{'id': 'EG000', 'title': 'Atlas', 'description': 'new base plate', 'otherNumAtRisk': 35, 'otherNumAffected': 6, 'seriousNumAtRisk': 35, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SenSura', 'description': 'base plate', 'otherNumAtRisk': 33, 'otherNumAffected': 1, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Conform2', 'description': 'base plate', 'otherNumAtRisk': 34, 'otherNumAffected': 6, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'faeces leakage under base plate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Leakage Under the Base Plate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Atlas', 'description': 'new base plate'}, {'id': 'OG001', 'title': 'SenSura', 'description': 'base plate'}, {'id': 'OG002', 'title': 'Conform2', 'description': 'base plate'}], 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '8.0', 'spread': '4.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At every change of base plate', 'description': 'Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atlas', 'description': 'New base plate\n\nAll subjects tested this test product in one period during the study.\n\nNo parcipitants recieved the same study intervention more than once'}, {'id': 'FG001', 'title': 'SenSura', 'description': 'Commercially available base plate\n\nAll subjects tested this test product in one period during the study.\n\nNo parcipitants recieved the same study intervention more than once'}, {'id': 'FG002', 'title': 'Conform2', 'description': 'Commercially available base plate\n\nAll subjects tested this test product in one period during the study.\n\nNo parcipitants recieved the same study intervention more than once'}], 'periods': [{'title': 'First Period (14 +/- 3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Second Period (14 +/- 3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Third Period (14 +/- 3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'not satisfied with product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from a user database in Denmark.', 'preAssignmentDetails': '41 subjects were enrolled, however 6 subjects did not comply with the inclusion and exclusion criteria. Four of these were terminated before testing any products. Whereas two subjects were included in the safety population as the inclusion criteria violation was first discovered after they tested a product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Parcipitants', 'description': 'All parcipitants recieved all three intervention and they are therefore combined into one group.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '2 subjects were excluded from the ITT and PP population, and therefore not included in the baseline measurements'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2010-04-13', 'resultsFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2010-04-13', 'lastUpdatePostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-22', 'studyFirstPostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leakage Under the Base Plate', 'timeFrame': 'At every change of base plate', 'description': 'Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ileostomy base plate'], 'conditions': ['Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.', 'detailedDescription': 'Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems.\n\nThe purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market.\n\nThe study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home.\n\n80 healthy participants with an ileostomy will be included in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written Informed Consent\n2. Are at least 18 years old\n3. Had their ileostomy for minimum 3 months with a size between 20-40 mm\n4. Have mental capacity to understand study guidelines and questionnaires\n5. Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.\n6. Experience leakage under the base plate at least one a week\n7. Are currently using a flat 2-piece base plate with mechanical coupling\n8. Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study\n\n \\-\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding\n2. Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.\n3. Currently receiving or have within the past 2 months received radio- and/or chemotherapy\n4. Currently using steroid product on peristomal skin (injections and oral treatment are accepted)\n5. Currently using a convex system\n6. Participating in other clinical studies or have previously participated in this study'}, 'identificationModule': {'nctId': 'NCT01103466', 'briefTitle': 'Investigation of the Performance of Ostomy Base Plate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH', 'orgStudyIdInfo': {'id': 'CP204OC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'New ostomy appliance (Atlas)', 'description': 'Atlas= new base plate. Due to company confidentiality the product is just called Atlas and this is not short for any other names', 'interventionNames': ['Device: Atlas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SenSura', 'description': 'Commercially available ostomy appliance', 'interventionNames': ['Device: SenSura']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conform 2', 'description': 'Commercially available ostomy appliance', 'interventionNames': ['Device: Conform 2']}], 'interventions': [{'name': 'Atlas', 'type': 'DEVICE', 'otherNames': ['ostomy appliance'], 'description': 'Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.', 'armGroupLabels': ['New ostomy appliance (Atlas)']}, {'name': 'SenSura', 'type': 'DEVICE', 'otherNames': ['ostomy appliance'], 'description': 'SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.', 'armGroupLabels': ['SenSura']}, {'name': 'Conform 2', 'type': 'DEVICE', 'otherNames': ['Ostomy appliance'], 'description': 'Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.', 'armGroupLabels': ['Conform 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Lis H Poulsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}