Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT01800903
Status:
COMPLETED
Last Update Posted:
2020-09-10
First Post:
2013-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Performance of a New Coating for Urinary Intermittent Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dktrm@coloplast.com', 'phone': '+45 4911 2174', 'title': 'Trine Møller Senior Clinical Manager', 'organization': 'Coloplast A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'All Participants', 'description': 'Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product.\n\nHowever for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Discomfort During Catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ZN-D Catheter', 'description': 'Subjects who tested the ZN-D catheter'}, {'id': 'OG001', 'title': 'ZN-C Catheter', 'description': 'Subjects who tested the ZN-C catheter'}, {'id': 'OG002', 'title': 'SpeediCath', 'description': 'Subjects who tested the Speedicath catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter', 'description': 'First SpeediCath catheter then ZN-D catheter then ZN-C catheter'}, {'id': 'FG001', 'title': 'SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter', 'description': 'First SpeediCath catheter then ZN-C catheter then ZN-D catheter'}, {'id': 'FG002', 'title': 'ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter', 'description': 'First ZN-D catheter then SpeediCath catheter then ZN-C catheter'}, {'id': 'FG003', 'title': 'ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter', 'description': 'First ZN-D catheter then ZN-C catheter then SpeediCath catheter'}, {'id': 'FG004', 'title': 'ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter', 'description': 'First ZN-C catheter then SpeediCath catheter then ZN-D catheter'}, {'id': 'FG005', 'title': 'ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter', 'description': 'First ZN-C catheter then ZN-D catheter then SpeediCath catheter'}], 'periods': [{'title': 'First Test Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Second Test Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'unable to catheterise', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Third Test Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '40 subjects were included in the safety population. 4 subjects discontinued because they were unable to catheterize with given catheter. these drop-outs were distributed evenly among the catheter types:\n\n1. subject: ZN-C\n2. subjects: ZN-D\n\n1 subjects: SC\n\nThese subjects were excluded from the ITT population as no endpoints were registered for them'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'The intention to treat population consists of 36 healthy male subjects'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2013-02-22', 'resultsFirstSubmitDate': '2013-11-29', 'studyFirstSubmitQcDate': '2013-02-26', 'lastUpdatePostDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-27', 'studyFirstPostDateStruct': {'date': '2013-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Discomfort During Catheterization', 'timeFrame': '1 day', 'description': 'Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Intermittent Urethral Catheterization']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have given written informed consent and signed letter of authority\n2. Be at least 18 years of age and have full legal capacity\n3. Be a male\n4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits\n\nExclusion Criteria:\n\n1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract\n2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)\n3. Participating in other interventional clinical investigations during this investigation (inclusion to termination) or have previously participated in this investigation (including run-in period)\n4. Known hypersensitivity toward any of the test products -'}, 'identificationModule': {'nctId': 'NCT01800903', 'briefTitle': 'Safety and Performance of a New Coating for Urinary Intermittent Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Coloplast A/S'}, 'officialTitle': 'Clinical Study Investigating Safety and Performance of a New Coating for Urinary Intermittent Catheters in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'CP235'}, 'secondaryIdInfos': [{'id': 'CP235', 'type': 'OTHER', 'domain': 'Coloplast'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sequence 1', 'description': 'SpeediCath catheter then ZN-D catheter then ZN-C catheter', 'interventionNames': ['Device: ZN-D catheter', 'Device: ZN-C catheter', 'Device: SpeediCath catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'SpeediCath catheter then ZN-C catheter then ZN-D catheter', 'interventionNames': ['Device: ZN-D catheter', 'Device: ZN-C catheter', 'Device: SpeediCath catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 3', 'description': 'ZN-D catheter then SpeediCath catheter then ZN-C catheter', 'interventionNames': ['Device: ZN-D catheter', 'Device: ZN-C catheter', 'Device: SpeediCath catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 4', 'description': 'ZN-D catheter then ZN-C catheter then SpeediCath catheter', 'interventionNames': ['Device: ZN-D catheter', 'Device: ZN-C catheter', 'Device: SpeediCath catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 5', 'description': 'ZN-C catheter then SpeediCath catheter then ZN-D catheter', 'interventionNames': ['Device: ZN-D catheter', 'Device: ZN-C catheter', 'Device: SpeediCath catheter']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 6', 'description': 'ZN-C catheter then ZN-D catheter then SpeediCath catheter', 'interventionNames': ['Device: ZN-D catheter', 'Device: ZN-C catheter', 'Device: SpeediCath catheter']}], 'interventions': [{'name': 'ZN-D catheter', 'type': 'DEVICE', 'description': 'ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'ZN-C catheter', 'type': 'DEVICE', 'description': 'ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}, {'name': 'SpeediCath catheter', 'type': 'DEVICE', 'description': 'The Speedicath cathere is CE-marked and commercially available.', 'armGroupLabels': ['Sequence 1', 'Sequence 2', 'Sequence 3', 'Sequence 4', 'Sequence 5', 'Sequence 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Urology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Per Bagi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Urology, Rigshospitalet Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coloplast A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}