Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-26 @ 11:41 PM
Study NCT ID:
NCT00637650
Status:
COMPLETED
Last Update Posted:
2009-02-10
First Post:
2008-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Fragments During Ureteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014545', 'term': 'Urinary Calculi'}], 'ancestors': [{'id': 'D052878', 'term': 'Urolithiasis'}, {'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': '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': 'NONE'}, 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-09', 'studyFirstSubmitDate': '2008-03-12', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'unplanned medical visits', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Hospital Admissions, need for pain killers, time to complete recovery', 'timeFrame': '60 days'}]}, 'conditionsModule': {'conditions': ['Urinary Stones']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the outcome of patients after ureteroscopy in which all fragments remaining after holmium laser lithotripsy were retrieved compared to those where small, insignificant fragments were left for spontaneous passage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with ureteral stones suitable for endoscopic treatment\n\nExclusion Criteria:\n\n* presence of ipsilateral kidney stones\n* known ureteral stricture\n* previous placement of ureteral stent\n* use of drugs with known activity on smooth ureteral muscle\n* unwillingness or impossibility to return for follow-up'}, 'identificationModule': {'nctId': 'NCT00637650', 'briefTitle': 'Management of Fragments During Ureteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'The Chaim Sheba Medical Center'}, 'officialTitle': 'Should we Strive for Absolute "Stone Freedom" While Performing Holmium Laser Lithotripsy for Ureteral Stones? A Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '4638'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Experimental group: patients in whom "stone dust" was left for spontaneous elimination', 'interventionNames': ['Procedure: Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment']}, {'type': 'OTHER', 'label': 'A', 'description': 'Control group: Patients in whom all fragments resulting from laser lithotripsy of ureteral stones were actively retrieved', 'interventionNames': ['Procedure: Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments']}], 'interventions': [{'name': 'Ureteroscopy, Holmium Laser lithotripsy and active retrieval of fragments', 'type': 'PROCEDURE', 'armGroupLabels': ['A']}, {'name': 'Ureteroscopy, Holmium laser lithotripsy, no intent to retrieve any remaining fragment', 'type': 'PROCEDURE', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'state': 'Ramat Gan', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Chaim Sheba Medical Center', 'class': 'OTHER'}}}}