Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2026-02-28 @ 3:30 AM
Study NCT ID:
NCT02746406
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2016-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sbitzos@laborie.com', 'phone': '9056121170', 'title': 'Clinical Researcher', 'phoneExt': '1755', 'organization': 'Laborie'}, 'certainAgreement': {'otherDetails': 'Sponsor can review results communications prior to public release regarding trial results for a period that is less than 60 days. The sponsor can request changes to the communication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Peritron+', 'description': 'SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter\n\nPeritron+: Peritron+ device to measure intravesical pressure', 'otherNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Peritron+', 'description': 'SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter\n\nPeritron+: Peritron+ device to measure intravesical pressure'}], 'classes': [{'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through study completion, an average of 4 days', 'description': 'Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peritron+', 'description': 'SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter\n\nPeritron+: Peritron+ device to measure intravesical pressure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Peritron+', 'description': 'SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter\n\nPeritron+: Peritron+ device to measure intravesical pressure'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2016-04-12', 'resultsFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-04-18', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-15', 'studyFirstPostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability Factors; Simple, Doable, and is Comparable to the Ruler-based Manometry Method Using a Questionnaire and Patient Diary.', 'timeFrame': 'Through study completion, an average of 4 days', 'description': 'Each participant could score between 0 and 39 and the total score range for group is 0 to 195. All questionnaires and patient diary questions were summed across the board for patients to derive a total score for the Arm/Group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urology']}, 'descriptionModule': {'briefSummary': "In a hospital setting, the self-measurement of intravesical pressure (SMIP) assessment will be conducted at full and empty bladder using the Peritron+ and a ruler-based manometry method. In the home setting a human factor/usability study will be conducted to measure the subject's ability to perform a successful SMIP assessment at full and empty bladder with the Peritron+. This study involves the use of the Peritron+, Air-Trap Tubing, a ruler and a clean intermittent catheter (CIC)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (2 to 18 years old)\n* Subjects who perform CIC regularly\n* Must be able to understand English instructions (written or oral)\n\nExclusion Criteria:\n\n* Subjects suffering from symptomatic bladder infection'}, 'identificationModule': {'nctId': 'NCT02746406', 'briefTitle': 'A Human Factor Study To Asses The Usability And Feasibility Of The Peritron+ During Intended Use', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laborie Medical Technologies Inc.'}, 'orgStudyIdInfo': {'id': 'PLUS-HF-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peritron+', 'description': 'SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter', 'interventionNames': ['Device: Peritron+']}], 'interventions': [{'name': 'Peritron+', 'type': 'DEVICE', 'description': 'Peritron+ device to measure intravesical pressure', 'armGroupLabels': ['Peritron+']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laborie Medical Technologies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}