Status:
NOT_YET_RECRUITING
Clinical Trial of VISOR vs fURS for Upper Urinary Tract Stone
Lead Sponsor:
Ningbo No. 1 Hospital
Conditions:
Urolithiasis, Calcium Oxalate
Ureteroscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective randomized controlled clinical study aims to evaluate the safety and efficacy of a novel Vortex Intelligence Stone Optimized Removal (VISOR,The experimental group) system compared to ...
Detailed Description
1. Study Background and Rationale Urolithiasis is a highly prevalent urological disease, ranking first among inpatient admissions in urology departments. It is characterized by high incidence and ...
Eligibility Criteria
Inclusion
- Patients with upper urinary tract stones and a cumulative stone diameter ≤3 cm;
- Patients scheduled to undergo "flexible ureteroscopic holmium laser lithotripsy";
- Age ≥18 years;
- Patients without psychiatric disorders or language dysfunction, capable of understanding the study and providing informed consent.
Exclusion
- Patients requiring bilateral lithotripsy in a single-stage ureteroscopic procedure;
- Ipsilateral hydronephrosis with \>4 cm renal pelvic separation;
- Patients with a history of open or laparoscopic renal and/or ureteral surgery;
- Fever (body temperature ≥38°C) due to urinary tract infection or other causes within one week prior to surgery;
- Pregnant women;
- Patients with severe systemic diseases, cardiac diseases, pulmonary insufficiency, or vital organ failure unable to tolerate anesthesia or surgery (ASA score ≥3);
- Patients with anatomical abnormalities such as polycystic kidney, horseshoe kidney, or ectopic kidney;
- Patients with coagulation disorders (e.g., INR \>2.0 or platelet count \<80×10⁹/L);
- Patients currently participating in other device or drug clinical trials;
- Patients deemed ineligible for the trial by the investigator.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07181759
Start Date
September 20 2025
End Date
December 31 2026
Last Update
September 18 2025
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