Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-27 @ 11:19 AM
Study NCT ID:
NCT02469766
Status:
UNKNOWN
Last Update Posted:
2016-08-30
First Post:
2015-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Upper Ureteric Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-28', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-06-10', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone free rate', 'timeFrame': '3 months', 'description': 'The stone free rate will be evaluated with non-contrast CT'}], 'secondaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '2 weeks', 'description': 'Complications will be classified according to modified Clavien Dindo'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ureteral stones', 'ureter', 'ureteroscopy', 'flexible', 'SWL'], 'conditions': ['Ureteric Stones']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.', 'detailedDescription': 'This study will be conducted to compare the success and complication rates of Flexible, Semi-rigid URS, and SWL approaches for proximal ureteric stones with size ≤1 cm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Radio-opaque stones\n* less than or equal 1 cm\n\nExclusion Criteria:\n\n* Active UTI\n* Coagulopathy\n* Pregnancy\n* Ureteric stricture'}, 'identificationModule': {'nctId': 'NCT02469766', 'briefTitle': 'Treatment of Upper Ureteric Stones', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'A Comparison Between Flexible Ureteroscopy, Semirigid Ureteroscopy and Extracorporeal Shockwaves Lithotripsy (SWL) in The Management of Proximal Ureteric Stones. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'upper ureteric stones'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal Shockwaves', 'description': 'Patients in this arm will undergo SWL', 'interventionNames': ['Procedure: SWL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Semirigid URS', 'description': 'Patients in this arm will undergo Semirigid Ureteroscopy', 'interventionNames': ['Procedure: Semirigid URS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flexible URS', 'description': 'Patients in this arm will undergo Flexible Ureteroscopy', 'interventionNames': ['Procedure: Flexible URS']}], 'interventions': [{'name': 'SWL', 'type': 'PROCEDURE', 'description': 'Patients in this arm will undergo SWL', 'armGroupLabels': ['Extracorporeal Shockwaves']}, {'name': 'Semirigid URS', 'type': 'PROCEDURE', 'description': 'Patients in this arm will undergo semirigid URS', 'armGroupLabels': ['Semirigid URS']}, {'name': 'Flexible URS', 'type': 'PROCEDURE', 'description': 'Patients in this arm will undergo Flexible URS', 'armGroupLabels': ['Flexible URS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakhlia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Muhammad M abdallateef, MD', 'role': 'CONTACT', 'email': 'seif_1901@yahoo.com', 'phone': '01009681644'}, {'name': 'Ahmed R EL-Nahas, MD', 'role': 'CONTACT', 'email': 'ar_el_nahas@yahoo.com', 'phone': '+20502202222', 'phoneExt': '1699'}], 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Muhamad M abdallateef, MD', 'role': 'CONTACT', 'email': 'seif_1901@yahoo.com', 'phone': '01009681644'}, {'name': 'Ahmed R EL-Nahas, MD', 'role': 'CONTACT', 'email': 'ar_el_nahas@yahoo.com', 'phone': '+20502202222', 'phoneExt': '1699'}], 'overallOfficials': [{'name': 'Ahmed M Shoma, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'muhamad muhamad abdallateef', 'investigatorAffiliation': 'Mansoura University'}}}}