Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT07159503
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-12
First Post:
2025-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
VISOR Versus PCNL for Treatment of 2-4cm Renal Stones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007669', 'term': 'Kidney 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': 'D014545', 'term': 'Urinary Calculi'}, {'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': 'D000074642', 'term': 'Nephrolithotomy, Percutaneous'}], 'ancestors': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-07', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-08-29', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stone-free rate within 24 hours', 'timeFrame': '24 hours after surgery', 'description': 'The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.'}], 'secondaryOutcomes': [{'measure': 'Stone-free rate at 1 month', 'timeFrame': '28 ± 7 days after surgery', 'description': 'The percentage of participants whose stones are completely cleared at 1 month after surgery, evaluated using CT or ultrasound.'}, {'measure': 'Operative Time', 'timeFrame': 'During surgery (Day 0)', 'description': 'Total time from the beginning to the end of the surgery, measured in minutes.'}, {'measure': 'Postoperative fever', 'timeFrame': '0-30 days after surgery', 'description': 'Incidence of participants experiencing a body temperature ≥38°C within 30 days after surgery.'}, {'measure': 'Postoperative ureteral stricture', 'timeFrame': '28 ± 7 days after surgery', 'description': 'Occurrence of ureteral narrowing detected by imaging within 1 month after surgery.'}, {'measure': 'Pain assessment (VAS score)', 'timeFrame': 'Postoperative Day 0-28', 'description': 'Participants report their pain using the Visual Analog Scale (VAS) at different time points postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Calculi', 'Kidney Stones']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL).\n\nThe main questions it aims to answer are:\n\nHow many participants are stone-free within 24 hours after surgery?\n\nHow many participants are stone-free 1 month after surgery?\n\nWhat side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL?\n\nDoes VISOR help keep kidney pressure stable during surgery?\n\nResearchers will compare VISOR to PCNL to see which treatment works better and is safer.\n\nParticipants will:\n\nBe randomly assigned to have surgery with either VISOR or PCNL.\n\nHave imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared.\n\nReturn for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging.\n\nAbout 170 people will take part in this study at cooperative hospitals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm\n* Age between 18 and 80 years, regardless of gender\n* Mentally sound and able to comprehend study details and provide informed consent\n\nExclusion Criteria:\n\n* Presence of ureteral stricture or history thereof\n* Previous open or laparoscopic renal and/or ureteral surgery\n* Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery\n* Pregnancy, lactation, or menstruation at the time of surgery\n* ASA classification \\> Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery\n* Renal anatomical anomalies such as polycystic kidney, horseshoe kidney, or ectopic kidney\n* Coagulation dysfunction (e.g., INR \\> 1.5 or platelet count \\< 80 × 10⁹/L)\n* Intraoperative failure to successfully place the ureteral access sheath'}, 'identificationModule': {'nctId': 'NCT07159503', 'briefTitle': 'VISOR Versus PCNL for Treatment of 2-4cm Renal Stones', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones', 'orgStudyIdInfo': {'id': '2025-134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: VISOR', 'description': 'Participants will undergo Vortex Intelligence Stone Optimized Removal.', 'interventionNames': ['Procedure: Vortex Intelligence Stone Optimized Removal']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCNL Group', 'description': 'Participants undergo standard percutaneous nephrolithotomy (PCNL) for renal stone removal.', 'interventionNames': ['Procedure: Percutaneous Nephrolithotomy (PCNL)']}], 'interventions': [{'name': 'Vortex Intelligence Stone Optimized Removal', 'type': 'PROCEDURE', 'description': 'Vortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications.', 'armGroupLabels': ['Experimental: VISOR']}, {'name': 'Percutaneous Nephrolithotomy (PCNL)', 'type': 'PROCEDURE', 'description': 'A standard PCNL technique will be performed according to institutional practice guidelines.', 'armGroupLabels': ['PCNL Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': '2nd Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Bohan Wang, MD., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital, School of Medicine, Zhejiang University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}