Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT01272869
Status:
COMPLETED
Last Update Posted:
2012-12-31
First Post:
2010-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkbir@coloplast.com', 'phone': '4549111111', 'title': 'Director Medical Affairs', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Sensura', 'description': 'The reference product is the SenSura product which is already commercially available', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Morfeus', 'description': 'The test product is the product with the proposed new filter (Morfeus)', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pristomal skin redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep disruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Abscess in the buttock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'units': 'Bags', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sensura', 'description': 'SenSura is the reference product and the product is already commercially available'}, {'id': 'OG001', 'title': 'Morfeus', 'description': 'The test product is the product with the proposed new filter (Morfeus)'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Daily or at every change of bag in a period of a maximum of 28 days', 'description': 'Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.', 'unitOfMeasure': 'percentage bags with ballooning', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Bags', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Intention to treat (ITT)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sensura First; Then Morfeus', 'description': 'The reference product is the SenSura product which is already commercially available'}, {'id': 'FG001', 'title': 'Morfeus First; Then Sensura', 'description': 'The test product with the Morfeus filter is the test product with the proposed new filter.'}], 'periods': [{'title': 'Period 1 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (14 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The subjects were recruited from a user data base in Denmark.', 'preAssignmentDetails': '20 subjects were enrolled and randomized in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sensura', 'description': 'The reference product is the SenSura product which is already commercially available'}, {'id': 'BG001', 'title': 'Morfeus', 'description': 'The test product is the product with the proposed new filter (Morfeus)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '13', 'groupId': 'BG000'}, {'value': '61', 'spread': '10', 'groupId': 'BG001'}, {'value': '60', 'spread': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2010-12-14', 'resultsFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2011-01-07', 'lastUpdatePostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-29', 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period.', 'timeFrame': 'Daily or at every change of bag in a period of a maximum of 28 days', 'description': 'Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'The aim of the current clinical investigation is to evaluate a new filter', 'detailedDescription': 'The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years of age and have full legal capacity.\n* Have given written informed consent.\n* Be able to fill in the Case Report Form.\n* Be ileostomy operated and have had a stoma for at least 6 months.\n* Experience ballooning at least once per week.\n* Be able to manage the bags themselves (application, removal).\n* Be able to use a flat base plate.\n* Have a stoma with a diameter less than 60 mm\n\nExclusion Criteria:\n\n* Persons who irrigate\n* Currently suffer from peristomal skin problems (i.e. bleeding or broken skin).\n* Currently receiving or have within the past 2 months received radio- and/or chemotherapy.\n* Pregnant or breastfeeding.\n* Participate in other test at the same time.'}, 'identificationModule': {'nctId': 'NCT01272869', 'briefTitle': 'Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags', 'orgStudyIdInfo': {'id': 'CP211OC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sensura', 'description': 'SenSura is the reference product and the product is already commercially available', 'interventionNames': ['Device: SenSura']}, {'type': 'EXPERIMENTAL', 'label': 'Morfeus', 'description': 'The test product is the product with the proposed new filter (Morfeus)', 'interventionNames': ['Device: Morfeus']}], 'interventions': [{'name': 'SenSura', 'type': 'DEVICE', 'description': 'The ostomy bag filter will be tested for a period of 14 days', 'armGroupLabels': ['Sensura']}, {'name': 'Morfeus', 'type': 'DEVICE', 'description': 'The new ostomy bag filter will be tested for a period of 14 days', 'armGroupLabels': ['Morfeus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Humlebæk', 'country': 'Denmark', 'facility': 'Coloplast A/S', 'geoPoint': {'lat': 55.9618, 'lon': 12.5341}}], 'overallOfficials': [{'name': 'Daniel Carter, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Coloplast A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}