Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-03 @ 10:16 AM
Study NCT ID:
NCT01994902
Status:
COMPLETED
Last Update Posted:
2016-01-12
First Post:
2013-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkbir@coloplast.com', 'phone': '+45 49111395', 'title': 'Medical Director', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Coloplast Test Product', 'description': 'Adverse events reported by subjects testing Coloplast test product', 'otherNumAtRisk': 125, 'otherNumAffected': 28, 'seriousNumAtRisk': 125, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'SenSura Convex Light', 'description': 'Adverse events reported by subjects testing SenSura Convex Light', 'otherNumAtRisk': 120, 'otherNumAffected': 14, 'seriousNumAtRisk': 120, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Skin irritations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 51, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 26, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'urinary tract infection', 'notes': 'unlikely related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute abdominal pain', 'notes': 'unlikely related to the device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastrientitis', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'stoma operation (revision of stome)', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'obstruction of stoma', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blocked stoma', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dehydration', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'renal failure', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe sepsis in contex of intra abdominal infection', 'notes': 'not related to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 120, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Degree of Leakage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}, {'units': 'baseplates', 'counts': [{'value': '1967', 'groupId': 'OG000'}, {'value': '1988', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Coloplast Test Product', 'description': 'Leakage results obtained while subjects tested the Coloplast test product'}, {'id': 'OG001', 'title': 'SenSura Convex Light', 'description': 'The leakage results obtained while subjects were testing SenSura Convex Light'}], 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 +/- 3 days', 'description': 'The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'baseplates', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The results presented above are the intention-to-treat results that were analysed as randomised. However, the adverse events are reported as treated and as 4 subjects did not follow the randomisation order there is a slight discrepancy between the participants number in the outcome and adverse events section.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'First Coloplast Test Product; Then SenSura Convex Light', 'description': 'The subjects test:\n\ntest period 1: Coloplast test product test period 2: SenSura Convex Light\n\n.'}, {'id': 'FG001', 'title': 'First SenSura Convex Light; Then Coloplast Test Product', 'description': 'The subjects test:\n\ntest period 1: SenSura Convex Light test period 2: Coloplast test product'}], 'periods': [{'title': 'Test Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'comment': 'Randomisation mistake:a subject randomised to SenSura Convex Light but tested Coloplast test product', 'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'comment': 'The subject testing Coloplast test product discontinued due to device deficiency with adverse event', 'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'device deficiency with adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'bag too small', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Test Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '129 subjects were randomized, but two of these subjects were not exposed to a product: one subject had a stoma diameter of 42 mm (violation to inclusion criteria no.8) and one subject had chemotherapy planned (exclusion criteria no.3). 127 subjects were therefore included in the ITT population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'The investigation is a cross-over investigation therefore the baseline data is given for the overall study population'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '14.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'one gender registration was missing', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Only subjects in the intention to treat population are included in the baseline population. These were the only subjects who tested the products.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 129}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-08', 'studyFirstSubmitDate': '2013-10-18', 'resultsFirstSubmitDate': '2015-11-03', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-08', 'studyFirstPostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Degree of Leakage', 'timeFrame': '28 +/- 3 days', 'description': 'The degree of leakage is measured using a 33-point scale measuring leakage under the baseplate, where 0 points represents the best possible outcome (no leakage) and 33 points the worst possible outcome (leakage on the whole baseplate).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stoma Ileostomy']}, 'descriptionModule': {'briefSummary': 'The aim of the investigation was to investigate the performance and safety of a new ostomy product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are at least 18 years of age and have full legal capacity.\n2. Has had an ileostomy for at least 3 months.\n3. Has used a convex ostomy product for the last month.\n4. Has given signed informed consent.\n5. Has experienced seeping under the baseplate at least three times during the last two weeks.\n6. Currently using a SenSura Convex product with midi, maxi or magnum bags.\n7. Currently using a 1-piece product or a 2-piece product with a mechanical coupling ("click coupling").\n8. Has an ileostomy with a diameter of max 33 mm (1-piece product) or less. Or Has an ileostomy with a diameter of 30 mm (2-piece product) or less.\n\nExclusion Criteria:\n\n1. Has a loop-ostomy (double-barrel ostomy or ostomy with two outlets).\n2. Are pregnant or breastfeeding.\n3. Currently receiving, or has within the past 2 months received radio- and/or chemotherapy.\n4. Currently receiving, or has within the past month received steroid treatment (adrenocortical hormone) systemically or locally in the peristomal area.\n5. Currently suffering from peristomal skin problems i.e. bleeding or broken (weeping) skin.\n6. Are currently participating in another clinical intervention study or have previously participated in this one.\n7. Has a fistula in the peristomal area or less than 2 cm from the edge of the baseplate.\n8. Has known hypersensitivity toward the test product.'}, 'identificationModule': {'nctId': 'NCT01994902', 'briefTitle': 'Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Investigation of Newly Developed 1-and 2-piece Convex Ostomy Products in Subjects With Ileostomy.', 'orgStudyIdInfo': {'id': 'CP232'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First Coloplast test product', 'description': 'The subjects test:\n\ntest period 1: Coloplast test product test period 2: SenSura Convex Light', 'interventionNames': ['Device: Coloplast test product', 'Device: SenSura Convex Light']}, {'type': 'EXPERIMENTAL', 'label': 'First SenSura Convex Light', 'description': 'The subjects test:\n\ntest period 1: SenSura Convex Light test period 2: Coloplast test product', 'interventionNames': ['Device: Coloplast test product', 'Device: SenSura Convex Light']}], 'interventions': [{'name': 'Coloplast test product', 'type': 'DEVICE', 'description': 'The Coloplast test product is a newly developed ostomy appliance', 'armGroupLabels': ['First Coloplast test product', 'First SenSura Convex Light']}, {'name': 'SenSura Convex Light', 'type': 'DEVICE', 'otherNames': ['SenSura'], 'description': 'The comparator product is SenSura Convex Light, which is CE-marked and commercially available.', 'armGroupLabels': ['First Coloplast test product', 'First SenSura Convex Light']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Søborg', 'country': 'Denmark', 'facility': 'TFS', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'Hopital du bocage', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '33505', 'city': 'Libourne', 'country': 'France', 'facility': 'Hopital Robert Boulin', 'geoPoint': {'lat': 44.91449, 'lon': -0.24186}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'Hopital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital de Haut Levêque', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHRU La Milétrie', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Aachen', 'country': 'Germany', 'facility': 'BB medica medizinisches', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Augsburg', 'country': 'Germany', 'facility': 'Sanitätshause reinhold hilscher e.K.', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Bad Staffelstein', 'country': 'Germany', 'facility': 'Patientenberatung Strack e.K.', 'geoPoint': {'lat': 50.10199, 'lon': 11.00128}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Pro-samed Santitätshaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Burgdorf, Hanover', 'country': 'Germany', 'facility': 'SIEWA coloplast Homecare', 'geoPoint': {'lat': 52.44628, 'lon': 10.0064}}, {'city': 'Freising', 'country': 'Germany', 'facility': 'SIEWA Coloplast Homecare', 'geoPoint': {'lat': 48.40351, 'lon': 11.74876}}, {'city': 'Leinfelden-Echterdingen', 'country': 'Germany', 'facility': 'SIEWA Coloplast homecare', 'geoPoint': {'lat': 48.69406, 'lon': 9.16809}}, {'city': 'Leipzig', 'country': 'Germany', 'facility': 'Schürmaier GmbH &Co', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Passau', 'country': 'Germany', 'facility': 'Sanitätshaus Fürst GmbH', 'geoPoint': {'lat': 48.5665, 'lon': 13.43122}}, {'city': 'Saulgrub', 'country': 'Germany', 'facility': 'SIEWA Coloplast Homecare', 'geoPoint': {'lat': 47.66643, 'lon': 11.02469}}, {'city': 'Töppeln', 'country': 'Germany', 'facility': 'Sanitäts- und gesundheitshaus Carqueville GmbH', 'geoPoint': {'lat': 50.88993, 'lon': 12.00593}}, {'city': 'Zwickau', 'country': 'Germany', 'facility': 'Alippi GmbH', 'geoPoint': {'lat': 50.72724, 'lon': 12.48839}}, {'city': 'Larvik', 'country': 'Norway', 'facility': 'Sykpleierklinikken', 'geoPoint': {'lat': 59.05328, 'lon': 10.03517}}, {'city': 'Boston', 'country': 'United Kingdom', 'facility': 'Pilgrim Hospital', 'geoPoint': {'lat': 52.97633, 'lon': -0.02664}}, {'zip': 'CB20QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrookes', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'GL53/AI', 'city': 'Gloucestershire', 'country': 'United Kingdom', 'facility': 'Cheltenham General Hospital'}, {'zip': 'LN25QY', 'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'Lincon Country hospital', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'zip': 'W68RF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Charing Cross Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NN168UZ', 'city': 'Northamptonshire', 'country': 'United Kingdom', 'facility': 'Kettering General hospital'}, {'zip': 'IP332QZ', 'city': 'Suffolk', 'country': 'United Kingdom', 'facility': 'west Suffolk Hospital'}], 'overallOfficials': [{'name': 'Daniel Carter', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}