Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-06 @ 8:01 PM
Study NCT ID:
NCT02362360
Status:
COMPLETED
Last Update Posted:
2016-10-11
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkcfv@coloplast.com', 'phone': '0045 49111990', 'title': 'Head of Clinical Operations', 'organization': 'Coloplast'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected during the study period: 42 days +/- 6 days', 'eventGroups': [{'id': 'EG000', 'title': 'Coloplast Test Product', 'description': 'Answers from subjects testing Coloplast test product', 'otherNumAtRisk': 51, 'otherNumAffected': 9, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparator', 'description': 'Answers from subjects testing Comparator', 'otherNumAtRisk': 49, 'otherNumAffected': 17, 'seriousNumAtRisk': 49, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Skin irritation', 'notes': 'related adverse events to either Test product or Comparator (adverse event categorised as unlikely related, probably related, possibly related and definitly related are treated as related adverse events).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 21, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Lung infection', 'notes': 'not related to Comparator product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Compartment syndrome in left lower leg', 'notes': 'not related to Comparator product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute renal failure', 'notes': 'not related to Comparator product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Coloplast Test Product', 'description': 'Answers from subjects testing Coloplast test product'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Answers from subjects testing Comparator'}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '56.9', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '27.7', 'groupId': 'OG001'}]}]}, {'title': 'Acceptable', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Very poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 +/- 3 days', 'description': 'Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".', 'unitOfMeasure': 'percentage of subjects answering', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coloplast Test Product Then Comparator', 'description': 'The subject first tests the Coloplast Test Product and then tests the Comparator\n\nColoplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S\n\nComparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.'}, {'id': 'FG001', 'title': 'Comparator Then Coloplast Test Product', 'description': 'The subject first tests the Comparator and then tests the Coloplast Test Product.\n\nColoplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S\n\nComparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One subject was a screen failure and was not exposed to any of the test products. This subject was excluded from the safety population, which therefore included 52 subjects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'All subjects included in the investigation'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.9', 'spread': '9.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2015-02-09', 'resultsFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2015-02-11', 'lastUpdatePostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-08-18', 'studyFirstPostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fit to the Peristomal Area, Measured by a 5-point Scale Ranging From "Very Poor" to "Very Good".', 'timeFrame': '21 +/- 3 days', 'description': 'Subjects will evaluate the fit to body for each product by answering the question "How was the baseplates ability to fit to the body contours in the area around the stoma?". The question is answered with a 5-point scale ranging from "very poor" to "very good".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ostomy'], 'conditions': ['Ileostomy', 'Colostomy']}, 'referencesModule': {'references': [{'pmid': '39037163', 'type': 'DERIVED', 'citation': 'Rolfsen T, Vestergaard M, Hansen MF, Boisen EB, Dambaek MR. Body Fit With a Pouching System With Concave Contour for People With an Outward Peristomal Body Profile: Effects on Leakage, Wear Time, and Quality of Life: A Randomized Controlled Cross-Over Trial. J Wound Ostomy Continence Nurs. 2024 Jul-Aug 01;51(4):303-311. doi: 10.1097/WON.0000000000001088. Epub 2024 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have given written informed consent and in DK: signed a letter of authority\n* Be at least 18 years of age and have full legal capacity\n* Have had their ileostomy or colostomy for at least 3 months\n* Able to use a baseplate size 15 to 40 mm\n* Be able to handle the product themselves\n* Normally experience faeces under the baseplate at least 3 times during 2 weeks\n* Currently using a 2-piece flat product with mechanical coupling\n* Willing to test both the Coloplast test product and the comparator product\n* Willing to use an open bag size maxi during the investigation\n* Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)\n* Willing to use at least 1 baseplate every 3rd day during the investigation\n* Is able to use a custom cut product\n* Be suitable for participating in the investigation\n\nExclusion Criteria:\n\n* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)\n* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed\n* Are pregnant or breastfeeding\n* Are participating in other interventional clinical investigations or have previously participated in this investigation\n* Use irrigation during the investigation (flush the intestines with water)\n* Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)\n* Have a loop ostomy\n* Have known hypersensitivity towards any of the products used in the investigation'}, 'identificationModule': {'nctId': 'NCT02362360', 'briefTitle': 'Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy', 'orgStudyIdInfo': {'id': 'CP255'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Coloplast Test Product then Comparator', 'description': 'The subject first tests the Coloplast Test Product and then tests the Comparator', 'interventionNames': ['Device: Coloplast Test Product', 'Device: Comparator (Hollister)']}, {'type': 'EXPERIMENTAL', 'label': 'Comparator then Coloplast Test Product', 'description': 'The subject first tests the Comparator and then tests the Coloplast Test Product.', 'interventionNames': ['Device: Coloplast Test Product', 'Device: Comparator (Hollister)']}], 'interventions': [{'name': 'Coloplast Test Product', 'type': 'DEVICE', 'description': 'A new 2-piece ostomy appliance developed by Coloplast A/S', 'armGroupLabels': ['Coloplast Test Product then Comparator', 'Comparator then Coloplast Test Product']}, {'name': 'Comparator (Hollister)', 'type': 'DEVICE', 'description': 'Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.', 'armGroupLabels': ['Coloplast Test Product then Comparator', 'Comparator then Coloplast Test Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2860', 'city': 'Soeborg', 'country': 'Denmark', 'facility': 'Trial Form Support ApS (TFS)'}, {'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin, Klinik für Allgemein-, Gefäß- und Thoraxchirurgie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '22045', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'SIEWA Coloplast Homecare', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '9713G12', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'QPS Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '3269', 'city': 'Larvik', 'country': 'Norway', 'facility': 'Sykepleierklinikken A/S, Larvik', 'geoPoint': {'lat': 59.05328, 'lon': 10.03517}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}