Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-06 @ 6:07 PM
Study NCT ID:
NCT05416502
Status:
UNKNOWN
Last Update Posted:
2022-06-13
First Post:
2021-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Distal Lumen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-09', 'studyFirstSubmitDate': '2021-11-16', 'studyFirstSubmitQcDate': '2022-06-09', 'lastUpdatePostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Passage', 'timeFrame': '3 months', 'description': 'The number of recruited individuals whose ureteral stones are found to be passed by their report and it is confirmed by ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ureter Stone']}, 'descriptionModule': {'briefSummary': 'Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ureter stones', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUreteral Stone smaller than 1 cm Volunteer to be enrolled\n\nExclusion Criteria:\n\nPyonephrosis Urinary Sepsis Untraceable Pain'}, 'identificationModule': {'nctId': 'NCT05416502', 'briefTitle': 'Prospective Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Distal Lumen', 'organization': {'class': 'INDUSTRY', 'fullName': "Hiram's Healthcare and Education Company"}, 'officialTitle': 'Prospective Observational Evaluation of the Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Diameter of the Most Narrow Part of the Distal Ureter', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Passage Observed', 'description': 'Enrolled patients whose stone and ureter diameters are obtained and their stone passage was successful during the follow-up.', 'interventionNames': ['Procedure: Ultrasound']}, {'label': 'Passage Not Observed', 'description': 'Enrolled patients whose stone and ureter diameters are obtained and their stone passage was not successful during the follow-up.', 'interventionNames': ['Procedure: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Enrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder.', 'armGroupLabels': ['Passage Not Observed', 'Passage Observed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Erzurum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatih Ozkaya, MD', 'role': 'CONTACT', 'email': 'fatih.ozkaya@atauni.edu.tr', 'phone': '+90 505 943 6892'}], 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Ozer U Cakici, MD, FEBU', 'role': 'CONTACT', 'email': 'ozerural@hotmail.com', 'phone': '+90 541 461 20 51'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'ipdSharing': 'YES', 'description': 'IPD will be shared among the following criteria:\n\n* As allowed to the degree which is allowed by the enrolled patients.\n* As required by the researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hiram's Healthcare and Education Company", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ataturk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}