Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-31 @ 3:46 PM
Study NCT ID:
NCT06987760
Status:
RECRUITING
Last Update Posted:
2025-05-23
First Post:
2025-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052878', 'term': 'Urolithiasis'}], 'ancestors': [{'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-02-15', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of ureteral access sheath insertion', 'timeFrame': 'From enrollment to completion of surgery', 'description': 'Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases'}], 'secondaryOutcomes': [{'measure': 'The condition of ureter injury', 'timeFrame': '24 hours', 'description': "The ureter was observed at exit of the ureteroscope and graded according to Traxer's proposed grading system."}, {'measure': 'Stone clearance rate', 'timeFrame': 'up to 8 weeks.', 'description': 'Residual stones less than 4 mm are considered to be free of residual stones.'}, {'measure': 'Operation time', 'timeFrame': '24 hours', 'description': 'The duration of the operation from start to finish.'}, {'measure': 'The incidence of surgical complications', 'timeFrame': '7 days', 'description': 'The occurrence of postoperative fever, urogenic sepsis and septic shock'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Urolithiasis', 'Ratio of Endoscope-Sheath Diameter', 'Flexible ureteroscope'], 'conditions': ['Ureter Injury', 'Urolithiasis; Lower Urinary Tract', 'Efficacy, Self']}, 'descriptionModule': {'briefSummary': 'Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.', 'detailedDescription': 'Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.\n\n2.Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.\n\n 2.Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.\n\n 6.Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.\n\n 8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.'}, 'identificationModule': {'nctId': 'NCT06987760', 'briefTitle': 'Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo No. 1 Hospital'}, 'officialTitle': 'Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials', 'orgStudyIdInfo': {'id': 'MNWK202401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7.5Fr fURS and 10Fr UAS', 'description': '7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.', 'interventionNames': ['Procedure: flexible ureteroscope urolithiasis']}, {'type': 'ACTIVE_COMPARATOR', 'label': '9.0Fr fURS and 12Fr UAS', 'description': '9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.', 'interventionNames': ['Procedure: flexible ureteroscope urolithiasis']}], 'interventions': [{'name': 'flexible ureteroscope urolithiasis', 'type': 'PROCEDURE', 'description': 'Using flexible ureteroscope combine with urethral access sheath to treatment urolithiasis', 'armGroupLabels': ['7.5Fr fURS and 10Fr UAS', '9.0Fr fURS and 12Fr UAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315010', 'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Fang, Dr', 'role': 'CONTACT', 'email': 'fanyruo@126.com', 'phone': '057487085111'}, {'name': 'Boyang Song, Dr', 'role': 'CONTACT', 'email': 'fyysongboyang@nbu.edu.cn', 'phone': '057487085111'}], 'facility': 'The First Affiliated Hospital of Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'Li Fang', 'role': 'CONTACT', 'email': 'fanyruo@126.com', 'phone': '+86-13586681743'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "The First People's Hospital of Fuyang District, Hangzhou City", 'class': 'UNKNOWN'}, {'name': 'The Central Hospital of Lishui City', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}