Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT04605835
Status:
UNKNOWN
Last Update Posted:
2020-10-28
First Post:
2020-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonic Visualization of Obstructive Uropathies in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 655}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2020-10-08', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasonic visualization of renal function damage and urodynamic disorders for obstructive uropathies in children.', 'timeFrame': 'up to 36 months', 'description': 'The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstructive uropathy', 'children', 'ultrasound', 'Doppler'], 'conditions': ['Obstructive Uropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.arrs.org/ARRSLIVE/Publications', 'label': 'American Journal of Roentgenology'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.', 'detailedDescription': "Relevance. The prevalence of congenital diseases of the genitourinary system is 0.5-7.5 per 1000 newborns; The high prevalence reflects the medical and social significance of the problem and determines the need to search for highly informative and safe diagnostic methods for the child's body, providing timely treatment, restoration of the somatic and social status of children.\n\nPurpose. Development of proposals and recommendations to improve the safety of urological examination of children with obstructive uropathy.\n\nMaterial and methods. The study is based on the analysis of the results of diagnosis and treatment of 655 children with congenital obstruction of the upper urinary tract. The complex of urological examination included clinical, laboratory, morphological, radiological, ultrasound research methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '60 in children with obstructive uropathies (30 children with congenital hydronephrosis and 30 children with congenital ureterohydronephrosis).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 655 children with congenital obstruction of the upper urinary tract\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT04605835', 'briefTitle': 'Ultrasonic Visualization of Obstructive Uropathies in Children', 'organization': {'class': 'OTHER', 'fullName': 'Samarkand State Medical Institute'}, 'officialTitle': 'Ultrasonic Visualization of Renal Function Damage and Urodynamic Disorders for Obstructive Uropathies in Children', 'orgStudyIdInfo': {'id': 'DGU 20200967'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main group', 'description': '484 children with congenital obstructive uropathies', 'interventionNames': ['Diagnostic Test: ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.']}], 'interventions': [{'name': 'ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.', 'type': 'DIAGNOSTIC_TEST', 'description': 'The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.', 'armGroupLabels': ['Main group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '140100', 'city': 'Samarkand', 'country': 'Uzbekistan', 'facility': 'Samarkand State Medical Institute', 'geoPoint': {'lat': 39.65456, 'lon': 66.96445}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samarkand State Medical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}