Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-21 @ 3:45 AM
Study NCT ID:
NCT05413603
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}], 'ancestors': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lithotripsy or nephrolithotripsy by Shock waves', 'timeFrame': 'from baseline to 3 months after the Lithotripsy date.', 'description': 'Incidence of success of Nephrolithotripsy by using Fluoroscopic shock waves or Ultrasonic shock waves in pediatric renal pelvic stones.'}], 'secondaryOutcomes': [{'measure': 'Complications of shockwave lithotripsy', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'to evaluate postoperative complications of the lithotripsy as :\n\n1. Incidence of Hematuria\n2. Incidence of Fever\n3. Incidence of UTI\n4. Serum creatinine level in blood\n5. Rate of hydronephrosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric renal stones', 'ultrasound shock waves', 'fluoroscope.'], 'conditions': ['Stone, Kidney', 'Child, Only']}, 'descriptionModule': {'briefSummary': 'Epidemiological studies have shown a progressive increase in the incidence of pediatric urolithiasis over the past few decades.', 'detailedDescription': 'Pediatric stone disease is considered endemic in developing nations including Turkey, Pakistan, and eastern countries. The introduction of SWL by Chaussy et al. in the early 1980s revolutionized the management of upper urinary tract calculus disease.\n\nReports of successful SWL in children were first published in 1986; then several reports showed safety, and stone-free rates comparable with those of adults. For successful SWL, accurate localization of the shock waves is performed by ultrasound (US) or fluoroscope (FS) to fully focus the shock waves on the stone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (2-16) years of age with radiopaque renal pelvic stones less than 20 mm\n\nExclusion Criteria:\n\n1. Previous percutaneous nephrolithotripsy at the same side.\n2. Previous renal exploration for stones at the same side.\n3. Positive urinary culture.\n4. Calyceal stones'}, 'identificationModule': {'nctId': 'NCT05413603', 'briefTitle': 'Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egymedicalpedia'}, 'officialTitle': 'Shock Wave Lithotripsy Using Fluoroscopic Versus Ultrasonic Localization for Pediatric Renal Stones.', 'orgStudyIdInfo': {'id': 'Mahmoud Moubarak'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fluoroscopic focus Shock wave lithotripsy', 'description': 'Shock wave lithotripsy, accurate localization of the shock waves is performed by the fluoroscope (FS) to fully focus the shock waves on the stone', 'interventionNames': ['Procedure: ultrasonic focus Shock wave lithotripsy', 'Procedure: fluoroscopic focus Shock wave lithotripsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasonic focus Shock wave lithotripsy', 'description': 'Shock wave lithotripsy, accurate localization of the shock waves is performed by the ultrasound (US), to fully focus the shock waves on the stone', 'interventionNames': ['Procedure: ultrasonic focus Shock wave lithotripsy', 'Procedure: fluoroscopic focus Shock wave lithotripsy']}], 'interventions': [{'name': 'ultrasonic focus Shock wave lithotripsy', 'type': 'PROCEDURE', 'description': 'successful Shock wave lithotripsy , accurate localization of the shock waves is performed by ultrasound (US) to fully focus the shock waves on the stone', 'armGroupLabels': ['fluoroscopic focus Shock wave lithotripsy', 'ultrasonic focus Shock wave lithotripsy']}, {'name': 'fluoroscopic focus Shock wave lithotripsy', 'type': 'PROCEDURE', 'description': 'successful Shock wave lithotripsy , accurate localization of the shock waves is performed by fluoroscope (FS) to fully focus the shock waves on the stone', 'armGroupLabels': ['fluoroscopic focus Shock wave lithotripsy', 'ultrasonic focus Shock wave lithotripsy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'country': 'Egypt', 'facility': 'Urology department - faculty of medicine, South Valley university', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'overallOfficials': [{'name': 'Mahmoud Moubarak, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology department - faculty of medicine, South Valley university.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egymedicalpedia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}