Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT01542593
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2012-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Ureteral Length Using Computed Tomography (CT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014514', 'term': 'Ureteral Calculi'}, {'id': 'D006869', 'term': 'Hydronephrosis'}, {'id': 'D014517', 'term': 'Ureteral Obstruction'}], 'ancestors': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D014515', 'term': 'Ureteral Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-29', 'studyFirstSubmitDate': '2012-02-16', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Agreement between measurement of ureteral length (Centimeters) measured by CT and by ureteral catheterization', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ureteral Calculi', 'Hydronephrosis', 'Ureteral Obstruction']}, 'descriptionModule': {'briefSummary': 'Proper selection of ureteral stent length might help in reducing comorbidities associated with ureteral stenting, currently there is no standardized way of measuring ureteral length.\n\nMeasurement of ureteral length according to Computed Tomography (CT) scan might provide useful information when selecting the length of a ureteral stent. Our aim in this study is to compare ureteral measurements using CT scan and measurement of actual ureteral length measured during ureteral stenting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing planned procedure involving ureteroscopy or ureteral stenting\n* Abdominal CT scan performed within 6 months prior to intervention\n\nExclusion Criteria:\n\n* Known iodine sensitivity\n* Patients with fever or hemodynamic instability planned for urgent operation\n* Severe immune compromized patients\n* Severe thrombocytopenia \\< 50,000'}, 'identificationModule': {'nctId': 'NCT01542593', 'acronym': 'URO-Y-2', 'briefTitle': 'Evaluating Ureteral Length Using Computed Tomography (CT)', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Evaluation of Ureteral Length Measurement by Computed Tomography (CT) to Actual Ureteral Length Measured by Ureteral Catheterization', 'orgStudyIdInfo': {'id': 'CMC-11-0051-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ureteral catheterization', 'description': 'During a planned procedure involving ureteroscopy or ureteral stenting, ureteral catheterization will be performed for the purpose of measuring exact ureteral length.\n\nMeasurement results will be compared to measurements performed on CT scan (obtained before surgery).', 'interventionNames': ['Device: Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR']}], 'interventions': [{'name': 'Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR', 'type': 'DEVICE', 'otherNames': ['Cook Urological Inc. open end ureteral catheter 5FR', 'Karl Storz cystoscope 19-22F'], 'description': 'During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length.\n\nMeasurement results will be compared to measurements performed on CT scan (obtained before surgery).', 'armGroupLabels': ['Ureteral catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Yuval Freifeld, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident , Urology Department, principal investigator, Medical doctor', 'investigatorFullName': 'Yuval Freifeld', 'investigatorAffiliation': 'Carmel Medical Center'}}}}