Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-03-09 @ 2:44 AM
Study NCT ID:
NCT03726502
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2017-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014514', 'term': 'Ureteral Calculi'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018666', 'term': 'Ureteroscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003950', 'term': 'Diagnostic Techniques, Urological'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-14', 'studyFirstSubmitDate': '2017-04-19', 'studyFirstSubmitQcDate': '2018-10-30', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate', 'timeFrame': '3 months after surgery', 'description': 'rate of patients without any residue of stone'}], 'secondaryOutcomes': [{'measure': 'operation time', 'timeFrame': 'at time of surgery', 'description': 'the time between insertion of ureteroscopy till insertion of catheter'}, {'measure': 'grade of kidney hydronephrosis', 'timeFrame': '3 months after surgery', 'description': 'grade of hydronephrosis is classified as: 0-4 grades'}, {'measure': 'ureteral injury', 'timeFrame': 'at time of surgery', 'description': 'ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ureteral Calculi', 'safety guide-wire', 'ureteroscopy'], 'conditions': ['Ureteral Calculi']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone', 'detailedDescription': 'While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ureteral stone who underwent ureteroscopy\n\nExclusion Criteria:\n\n* transplant kidney\n* coagulopathy disorders\n* history of ureteral stenosis\n* skeletal disorders'}, 'identificationModule': {'nctId': 'NCT03726502', 'briefTitle': 'Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone', 'orgStudyIdInfo': {'id': 'Q12133'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ureteroscopy with safety guide-wire', 'description': 'ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy', 'interventionNames': ['Procedure: ureteroscopy with safety guide-wire', 'Procedure: with safety guide-wire']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ureteroscopy alone', 'description': 'ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy', 'interventionNames': ['Procedure: ureteroscopy alone', 'Procedure: without safety guide-wire']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'with safety guide-wire', 'description': 'ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy', 'interventionNames': ['Procedure: ureteroscopy with safety guide-wire', 'Procedure: with safety guide-wire']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'without safety guide-wire', 'description': 'ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy', 'interventionNames': ['Procedure: ureteroscopy alone', 'Procedure: without safety guide-wire']}], 'interventions': [{'name': 'ureteroscopy with safety guide-wire', 'type': 'PROCEDURE', 'description': 'ureteroscopy with use of safety guide-wire in treatment of ureteral stone', 'armGroupLabels': ['ureteroscopy with safety guide-wire', 'with safety guide-wire']}, {'name': 'ureteroscopy alone', 'type': 'PROCEDURE', 'description': 'ureteroscopy without use of safety guide-wire in treatment of ureteral stone', 'armGroupLabels': ['ureteroscopy alone', 'without safety guide-wire']}, {'name': 'without safety guide-wire', 'type': 'PROCEDURE', 'description': 'ureteroscopy without use of safety guide-wire in treatment of ureteral stone', 'armGroupLabels': ['ureteroscopy alone', 'without safety guide-wire']}, {'name': 'with safety guide-wire', 'type': 'PROCEDURE', 'description': 'ureteroscopy with use of safety guide-wire in treatment of ureteral stone', 'armGroupLabels': ['ureteroscopy with safety guide-wire', 'with safety guide-wire']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehrān', 'country': 'Iran', 'facility': 'Shahid beheshty university of medical sciences', 'geoPoint': {'lat': 27.45845, 'lon': 55.47624}}], 'overallOfficials': [{'name': 'Abbas Basiri, prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Shahid beheshty university of medical sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Hamidreza Shemshaki', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}