Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT00547820
Status:
COMPLETED
Last Update Posted:
2009-10-28
First Post:
2007-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Urinary Sensor for Cystourethrography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-27', 'studyFirstSubmitDate': '2007-10-20', 'studyFirstSubmitQcDate': '2007-10-22', 'lastUpdatePostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiation dose during VCUG procedure'}]}, 'conditionsModule': {'keywords': ['radiation dose', 'VCUG', 'pediatric patients'], 'conditions': ['Radiation Dose During VCUG']}, 'descriptionModule': {'briefSummary': 'Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients', 'detailedDescription': 'It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to know exactly when a child will start voiding, so the child is intermittently imaged by fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible. We suggest application of small urinary sensor in the perineum of the patient, that will signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor should cut down substantially radiation dose to the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children referred for VCUG procedure at out department\n\nExclusion Criteria:\n\n* children with pacemakers\n* decline to participate'}, 'identificationModule': {'nctId': 'NCT00547820', 'briefTitle': 'Urinary Sensor for Cystourethrography', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Urinary Sensor for Cystourethrography', 'orgStudyIdInfo': {'id': 'OBrook2518CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'with application of urinary sensor', 'interventionNames': ['Device: Urinary sensor']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'without use of urinary sensor', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['B']}, {'name': 'Urinary sensor', 'type': 'DEVICE', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Department of Diagnostic Imaging, Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Olga R Brook, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Diagnostic Imaging, Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}