Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT07089394
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrograde Intrarenal Surgery for Renal Stones in Pediatrics: A Prospective Analysis of Feasibility and Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-01', 'size': 394605, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-21T20:57', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-21', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-07-21', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stone free rate', 'timeFrame': 'within 2 months after intervention', 'description': 'stone free rate as proved by ctut ,defined as fragments ≤2 mm fragment'}], 'secondaryOutcomes': [{'measure': 'complication rate among all groups', 'timeFrame': 'intra, post operative, untill stent removal or within 2 months after intervention', 'description': 'complication rate over all and in each pediatric group in comparative analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'renal stones', 'flexible ureteroscopy', 'holmium laser'], 'conditions': ['Renal Stones', 'Pediatric Renal Stones']}, 'descriptionModule': {'briefSummary': 'it is an interventional single arm study for treating pediatric renal stones≤2cm by FURS and Holmium laser fragmentation.pediatric groups is benig compared for stone free rate, complication rate , success rate. 3 groups of children . group 1 up to 6 years, group 2 from 7 to 12 years , group 3 from 13 to 18 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric renal stones ≤2cm indicated for treatment\n\nExclusion Criteria:\n\n* congenital urinary tract anomalies, coagulation disorders, active uti,distal ureteric obstruction, bigger stone size'}, 'identificationModule': {'nctId': 'NCT07089394', 'acronym': 'RIRS pediatric', 'briefTitle': 'Retrograde Intrarenal Surgery for Renal Stones in Pediatrics: A Prospective Analysis of Feasibility and Outcomes.', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Retrograde Intrarenal Surgery for Renal Stones in Pediatrics: A Prospective Analysis of Feasibility and Outcomes.', 'orgStudyIdInfo': {'id': '7603'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'pediatric patients presented with ≤2cm renal stones within 2 years from jan 2023 to jan 2025', 'description': 'treatment of pediatric renal stones ≤2cmwith flexible URS +Holmium laser fragmentation', 'interventionNames': ['Procedure: flexible urs']}], 'interventions': [{'name': 'flexible urs', 'type': 'PROCEDURE', 'otherNames': ['RIRS', 'FURS'], 'description': 'treating pediatric renal stones with flexible urs+holmium laser fragmentation', 'armGroupLabels': ['pediatric patients presented with ≤2cm renal stones within 2 years from jan 2023 to jan 2025']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'AlAzhar university hospitals/Urology department', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '2025 till 2026', 'ipdSharing': 'YES', 'description': 'IPD used in the results and publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'urology assistant lecturer', 'investigatorFullName': 'Emad Gouda', 'investigatorAffiliation': 'Al-Azhar University'}}}}