Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-03-24 @ 11:44 PM
Study NCT ID:
NCT02658903
Status:
UNKNOWN
Last Update Posted:
2016-01-20
First Post:
2015-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2015-11-20', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial biofilm on catheter, assessed by ultrasonic culture of catheter tip removed at the end of the study.', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Significant bacteriuria assessed by weekly bacterial cultures.', 'timeFrame': 'every week during 4 weeks'}, {'measure': 'Clinically symptomatic catheter associated lower urinary infections.', 'timeFrame': '4 weeks'}, {'measure': 'occurence of adverse events', 'timeFrame': 'within 4 weeks', 'description': 'safety endpoint'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Foley', 'Infection', 'Hospital acquired', 'catheter associated', 'urinary'], 'conditions': ['Urinary Infections']}, 'descriptionModule': {'briefSummary': 'The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.', 'detailedDescription': 'This study is an open randomized controlled trial of 4 weeks duration. The intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. The catheter is used in patients which require longterm urinary catheterization over at least 1 month.\n\nThe endpoint is bacteriological exam and the laboratory is blinded to the therapy status. Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. A colonization rate of \\>95% is anticipated in the control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. Most patients have spinal cord injury and are treated by the prinicpal investigator.\n\nExclusion Criteria:\n\n* Need for antibiotic treatment for any infections\n* Urological intervention or need for catheter change within study duration of 4 weeks'}, 'identificationModule': {'nctId': 'NCT02658903', 'briefTitle': 'Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Oxys Medical AG'}, 'officialTitle': 'Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter', 'orgStudyIdInfo': {'id': 'Oxys-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study arm with Oxys-Cathter', 'description': 'The study group is treated with a modified urinary catheter, which delivers electromagnetic therapy to prevent and treat bacterial colonization during the study period. The intervention is the insertion of the study urinary catheter (foley) into the bladder.', 'interventionNames': ['Device: Oxys Catheter']}, {'type': 'OTHER', 'label': 'Control-arm with commercial catheter', 'description': 'The control group is treated with a commercial urinary catheter. The intervention is the insertion of the control urinary catheter (foley) into the bladder,', 'interventionNames': ['Device: Covidien Mona-Therm Foley catheter']}], 'interventions': [{'name': 'Oxys Catheter', 'type': 'DEVICE', 'description': 'The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.', 'armGroupLabels': ['Study arm with Oxys-Cathter']}, {'name': 'Covidien Mona-Therm Foley catheter', 'type': 'DEVICE', 'description': 'The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.', 'armGroupLabels': ['Control-arm with commercial catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Thomas Kessler, Prof., MD', 'role': 'CONTACT', 'email': 'Thomas.Kessler@balgrist.ch', 'phone': '0041 44 386 11 11'}, {'name': 'Ulrich Menert, MD', 'role': 'CONTACT', 'email': 'Ulrich.Mehnert@balgrist.ch', 'phone': '0041 44 386 56 68'}], 'facility': 'University Hospital Balgrist', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Christoph Scharf, MD', 'role': 'CONTACT', 'email': 'christoph.scharf@gmail.com', 'phone': '++41763322969'}, {'name': 'Christine Tivig, MD', 'role': 'CONTACT', 'email': 'ki.tivig@gmail.com', 'phone': '+41 787358855'}], 'overallOfficials': [{'name': 'Thomas Kessler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik Balgrist Zürich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxys Medical AG', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}