{ "FullStudy":{ "Rank":217761, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517178", "OrgStudyIdInfo":{ "OrgStudyId":"CP215OC" }, "Organization":{ "OrgFullName":"Coloplast A/S", "OrgClass":"INDUSTRY" }, "BriefTitle":"Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care", "OfficialTitle":"An Open-labelled, Randomised, Controlled, Comparative, Multi-national, Cross-over Study Investigating the Safety and Performance of a New 2-piece Ostomy Product Compared to 2-piece Standard Care Ostomy Products" }, "StatusModule":{ "StatusVerifiedDate":"March 2015", "OverallStatus":"Terminated", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"June 24, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"March 3, 2015", "ResultsFirstSubmitQCDate":"March 3, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 13, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 3, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 13, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Coloplast A/S", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The primary object of this study is to provide clinical documentation for the New base plate significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care base plates.\n\nThe secondary objectives are to provide clinical documentation on several performance and safety parameters on the New base plate compared to Standard Care base plates.\n\nThe primary hypothesis is that the New base plate significantly reduces degree of leakage under the base plate compared to Standard Care base plates.\n\nEach test period will last for two weeks. In addition to this there will be one week run-in period on New base plate. The data will be collected by investigator in the Case Report Form at the inclusion visit, cross-over visit and termination visit. Data will also be collected by the subject in a questionnaire during the two test periods.\n\nThe subjects will change their base plates on per need basis and continue with their normal changing pattern in the entire study period.\n\n100 subjects with ileostomy will be included in the study. The subjects will be recruited from Europe including Denmark, Norway, Sweden, Iceland, Germany and France." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Leakage", "Skin Condition" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"33", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Standard Care base plate", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Standard care are the participants own product and can have several manufacture and brand names", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: Standard Care base plate" ] } },{ "ArmGroupLabel":"New ostomy base plate (SS)", "ArmGroupType":"Experimental", "ArmGroupDescription":"SS = New ostomy base plate. Due to company confidentiality the product is called SS and this is not short for any name", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Device: New ostomy base plate (SS)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Device", "InterventionName":"New ostomy base plate (SS)", "InterventionDescription":"The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "New ostomy base plate (SS)" ] } },{ "InterventionType":"Device", "InterventionName":"Standard Care base plate", "InterventionDescription":"The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Standard Care base plate" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Degree of Output Under the Base Plate (Leakage).", "PrimaryOutcomeDescription":"Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).", "PrimaryOutcomeTimeFrame":"Each test product was assessed for 2 weeks." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHave given written Informed Consent\nIs at least 18 years old\nHas the mental capacity to understand the study guidelines and questionnaires\nHas had their ileostomy for at least 3 months\nHas an ileostomy with a diameter between 19-40 mm\nIs currently using a flat 2-piece product with with mechanical coupling\nIs able to change the base plate by themselves or with help from a caregiver (e.g. spouse)\nHas experienced leakage under the base plate at least once a week over the last 2 weeks\n\nExclusion Criteria:\n\nIs pregnant or breast-feeding\nCurrently receiving or has within the past 2 months received radio- and/or chemotherapy\nCurrently using topical steroid product on peristomal skin (injections and oral treatment are accepted)\nIs currently using a convex base plate\nParticipating in other clinical studies or has previously participated in this study", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Sygehus Sønderjylland i Aabenraa", "LocationCity":"Aabenraa", "LocationZip":"6200", "LocationCountry":"Denmark" },{ "LocationFacility":"Bispebjerg Hospital", "LocationCity":"Copenhagen", "LocationZip":"2400", "LocationCountry":"Denmark" },{ "LocationFacility":"Hvidovre Hospital", "LocationCity":"Hvidovre", "LocationZip":"2650", "LocationCountry":"Denmark" },{ "LocationFacility":"Odense Universitetshospital", "LocationCity":"Odense", "LocationZip":"5000", "LocationCountry":"Denmark" },{ "LocationFacility":"Hôpital Nord", "LocationCity":"Marseille", "LocationZip":"13015", "LocationCountry":"France" },{ "LocationFacility":"Hôpital Hôtel Dieu de Nantes", "LocationCity":"Nantes cedex 1", "LocationZip":"44093", "LocationCountry":"France" },{ "LocationFacility":"Hôpital Lariboisière", "LocationCity":"Paris cedex 10", "LocationZip":"75475", "LocationCountry":"France" },{ "LocationFacility":"CHRU La Milétrie", "LocationCity":"Poitiers cedex", "LocationZip":"86021", "LocationCountry":"France" },{ "LocationFacility":"Hôpital de Pontchaillou, CHRU de Rennes", "LocationCity":"Rennes cedex 9", "LocationZip":"35033", "LocationCountry":"France" },{ "LocationFacility":"Sanitätshaus Fürst GmbH", "LocationCity":"Passau", "LocationZip":"94032", "LocationCountry":"Germany" },{ "LocationFacility":"Landspitali University Hospital", "LocationCity":"Reykjavik", "LocationZip":"108", "LocationCountry":"Iceland" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"A total of 33 subjects were enrolled in the trial. Of these, 6 discontinued during the New ostomy base plate run-in period prior to period 1 and were excluded from the Intention-To-Treat analysis set (no performance data obtained). 27 subjects comprised the intention-to-treat population.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Standard Care - New Ostomy Base Plate", "FlowGroupDescription":"Subjects first test Standard Care then New ostomy base plate." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"New Ostomy Base Plate - Standard Care", "FlowGroupDescription":"Subjects first test New ostomy base plate then Standard Care." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Period 1", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"One subject (who discontinued due to an adverse event) actually used New ostomy base plate.", "FlowAchievementNumSubjects":"16" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"11" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"12" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"4" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"5" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"E.g. study termination", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" } ] } } ] } },{ "FlowPeriodTitle":"Period 2", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementComment":"One subject discontinued during run-in and did not start period 2.", "FlowAchievementNumSubjects":"11" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"5" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"4" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"6" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"2" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"E.g. study termination", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Intention-to-treat Analysis Set" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"27" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"54.9", "BaselineMeasurementSpread":"12.8" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"France", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" } ] } } ] } },{ "BaselineClassTitle":"Denmark", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" } ] } } ] } },{ "BaselineClassTitle":"Iceland", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } },{ "BaselineClassTitle":"Germany", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Degree of Output Under the Base Plate (Leakage).", "OutcomeMeasureDescription":"Degree of output is measured by a 24-point leakage assessment scale (0 indicating no leakage and 24 indicating maximum leakage).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"units on a scale", "OutcomeMeasureTimeFrame":"Each test product was assessed for 2 weeks.", "OutcomeMeasureTypeUnitsAnalyzed":"Baseplates", "OutcomeMeasureDenomUnitsSelected":"Participants", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Standard Care Base Plate" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"New Ostomy Base Plate" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"22" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"22" } ] } },{ "OutcomeDenomUnits":"Baseplates", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"122" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"104" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4.6", "OutcomeMeasurementSpread":"3.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.5", "OutcomeMeasurementSpread":"5.0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Standard Care Base Plate", "EventGroupDescription":"Safety population includes subjects allocated to test period (no run-in period)", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"21", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"21" },{ "EventGroupId":"EG001", "EventGroupTitle":"New Ostomy Base Plate", "EventGroupDescription":"Safety population includes subjects allocated to run-in period and test period.", "EventGroupSeriousNumAffected":"1", "EventGroupSeriousNumAtRisk":"30", "EventGroupOtherNumAffected":"13", "EventGroupOtherNumAtRisk":"30" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Infection in parastomal prosthetic mesh", "SeriousEventOrganSystem":"Infections and infestations", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventNotes":"Not related to the product", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"21" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"30" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Peristomal skin irritation", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Adverse event related or possibly related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"21" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"30" } ] } },{ "OtherEventTerm":"Adhesive issue", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Adverse event related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"21" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"9", "OtherEventStatsNumAffected":"9", "OtherEventStatsNumAtRisk":"30" } ] } },{ "OtherEventTerm":"Lack of effectiveness", "OtherEventOrganSystem":"Skin and subcutaneous tissue disorders", "OtherEventAssessmentType":"Systematic Assessment", "OtherEventNotes":"Adverse event related to the product", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"0", "OtherEventStatsNumAffected":"0", "OtherEventStatsNumAtRisk":"21" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"1", "OtherEventStatsNumAffected":"1", "OtherEventStatsNumAtRisk":"30" } ] } } ] } }, "MoreInfoModule":{ "LimitationsAndCaveats":{}, "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"LTE60", "AgreementRestrictiveAgreement":"Yes" }, "PointOfContact":{ "PointOfContactTitle":"Tonny Karlsmark", "PointOfContactOrganization":"Bispebjerg Hospital", "PointOfContactEMail":"tkar0002@bbh.regionh.dk" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012871", "ConditionMeshTerm":"Skin Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M14257", "ConditionBrowseLeafName":"Skin Diseases", "ConditionBrowseLeafAsFound":"Skin Conditions", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC17", "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }