Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT05759767
Status:
UNKNOWN
Last Update Posted:
2023-03-10
First Post:
2023-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D014545', 'term': 'Urinary 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': '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': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-08', 'studyFirstSubmitDate': '2023-02-26', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2023-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the Stone-free rate (SFR) between groups', 'timeFrame': 'three months', 'description': 'SFR is defined as complete stone removal without visible stone fragments on radiological studies assessed by Low dose Non Contrast Computed Tomography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Shock Wave Lithotripsy', 'tamsulosin'], 'conditions': ['Tamsulosin', 'Extracorporeal Shock Wave Lithotripsy', 'Stone, Kidney', 'Stone, Urinary', 'Pediatric Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radio- opaque renal stone ≤ 2 cm or ≤ 1cm lower calyceal stone\n* Normal kidney function.\n\nExclusion Criteria:\n\n* Bleeding diatheses\n* Uncontrolled UTIs\n* Severe skeletal malformations'}, 'identificationModule': {'nctId': 'NCT05759767', 'briefTitle': 'The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis', 'orgStudyIdInfo': {'id': 'Ped MET SWL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin', 'description': 'Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Children in this group will receive Placebo for 3 weeks after ESWL session.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Children in this group will receive medical expulsive therapy in the form of (tamsulosin at a dose of 0.01 mg/kg once daily for 3 weeks after ESWL session.', 'armGroupLabels': ['Tamsulosin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Children in this group will receive placebo once daily for 3 weeks after ESWL session.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}