Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-03-05 @ 5:32 PM
Study NCT ID:
NCT02279927
Status:
UNKNOWN
Last Update Posted:
2014-10-31
First Post:
2014-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Comparison Between Different Laser Settings for Ureteral \ Kidney Stones Treatment During Ureteroscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}]}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-29', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-10-29', 'lastUpdatePostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rate', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Duration of operation', 'timeFrame': 'Immediate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ureteroscopy'], 'conditions': ['Ureterolithiasis', 'Nephrolithiasis']}, 'descriptionModule': {'briefSummary': 'A prospective study comparing different laser settings used for stone fragmentation during ureteroscopy', 'detailedDescription': 'Two groups prospectively randomized for different laser settings during ureteroscopy one aimed for stone dusting, the other for stone fragmentation and basket extraction of fragments'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are planned for ureteroscopy \\\\ retrograde intra renal surgery (RIRS) for stone treatment\n\nExclusion Criteria:\n\n* known ureteral stricture\n* severe immune deficiency\n* patients after urinary diversion surgery\n* patients with single \\\\ ectopic\\\\ implanted kidney\n* double collecting system\n* severe thrombocytopenia\n* patients taking anticoagulant drugs that cannot be stooped before the operation'}, 'identificationModule': {'nctId': 'NCT02279927', 'briefTitle': 'Prospective Comparison Between Different Laser Settings for Ureteral \\ Kidney Stones Treatment During Ureteroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Prospective Comparison Between Different Laser Settings for Ureteral \\ Kidney Stones Treatment During', 'orgStudyIdInfo': {'id': 'CMC-14-0063-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low energy high frequency', 'description': 'Ureteroscopy with laser settings of low energy \\& high frequency with aim of stone dusting', 'interventionNames': ['Device: Ureteroscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High energy low frequency', 'description': 'Ureteroscopy with laser settings of low energy high frequency with aim of stone fragmentation and basket extraction of fragments', 'interventionNames': ['Device: Ureteroscopy']}], 'interventions': [{'name': 'Ureteroscopy', 'type': 'DEVICE', 'description': 'Ureteroscopy with laser stone fragmentation', 'armGroupLabels': ['High energy low frequency', 'Low energy high frequency']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yuval Freifeld', 'role': 'CONTACT', 'email': 'yuvalfr@clalit.org.il', 'phone': '+97248250843'}, {'name': 'Yuval Freifeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yuval Freifeld', 'role': 'CONTACT', 'email': 'yuvalfr@clalit.org.il', 'phone': '+97248250843'}], 'overallOfficials': [{'name': 'Yuval Freifeld', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Carmel MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}