Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-31 @ 11:32 PM
Study NCT ID:
NCT02911051
Status:
COMPLETED
Last Update Posted:
2018-01-25
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-23', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-09-20', 'lastUpdatePostDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence', 'timeFrame': 'All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Intermittent Urethral Catheterization']}, 'descriptionModule': {'briefSummary': 'The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. male patient\n2. patient is at least 18 years old\n3. patient having normal or impaired sensation in the urethra\n4. patient catheterizing at least 4 times a day\n5. patient using Ch 12 or 14 catheter for self clean urinary catheterization\n6. patient using a Nelaton catheter for self clean urinary catheterization\n7. patient using self clean urinary catheterization for at least one month\n8. patient covered with social insurance\n\nExclusion Criteria:\n\n1. patient having a symptomatic urinary tract infection as assessed by the investigator (5 days after end of treatment for UTI, patient can be considered by the investigator for inclusion)\n2. patient with urethral hypersensitivity\n3. patient being mentally unstable not being assessed by the investigator as capable to follow the study procedure\n4. patient already participating in another clinical study or who have previously participated in this investigation'}, 'identificationModule': {'nctId': 'NCT02911051', 'briefTitle': 'Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'BBraun Medical SAS'}, 'officialTitle': 'Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients', 'orgStudyIdInfo': {'id': 'OPM-G-H-1303'}, 'secondaryIdInfos': [{'id': '2014-A01774-43-A', 'type': 'OTHER', 'domain': 'French Health Autority'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Actreen Hydrolite Cath', 'description': 'a new hydrophilic coated catheter for Urinary Intermittent Catheterisation', 'interventionNames': ['Device: Actreen Hydrolite Cath']}], 'interventions': [{'name': 'Actreen Hydrolite Cath', 'type': 'DEVICE', 'description': 'Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day', 'armGroupLabels': ['Actreen Hydrolite Cath']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garches', 'country': 'France', 'facility': 'Chartier-Kastler', 'geoPoint': {'lat': 48.84226, 'lon': 2.18232}}], 'overallOfficials': [{'name': 'Chartier-Kastler Emmanuel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôspital Raymond Poincaré - Garches'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BBraun Medical SAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}