Clinical Trial of VISOR vs fURS for Upper Urinary Tract Stone

NCT07181759 | Not Yet Recruiting

• 1 other identifier: 2025-R042-02
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 a single-use ureterorenoscope (the control) for treating upper urinary tract stones. A total of 100 patients with upper urinary tract stones (cumulative stone diameter ≤3 cm) will be enrolled and randomly assigned in a 1:1 ratio to either the experimental group (n=50) or the control group (n=50). The experimental group will undergo surgery using the innovative system, which integrates irrigation-suction, pressure monitoring-regulation, and lithotripsy-evacuation functions. The control group will be treated with a conventional single-use ureterorenoscope. The primary outcome measure is the immediate stone-free rate (SFR), defined as the proportion of patients with residual fragments \<4 mm on renal non-contrast computed tomography (NCCT) performed within 24 hours postoperatively. Key secondary endpoints include the SFR at 3 months, operative and lithotripsy times, total laser energy used, intraoperative ureteral injury (Traxer grading), postoperative pain scores, incidence of fever (\>38.0°C), and overall complication rates (Clavien-Dindo classification). Patient follow-up assessments will be conducted at 24 hours, 21±7 days, and 90±14 days post-surgery to monitor stone clearance, complications, and recovery. This study seeks to determine if the novel system offers superior stone clearance while maintaining a safe renal pelvic pressure profile, potentially improving outcomes for patients with larger renal stones treated ureteroscopically.

Conditions

Urolithiasis, Calcium Oxalate; Ureteroscopy; Therapeutic Irrigation; Intraoperative Complications

Keywords

Ureterorenoscopy; Upper urinary tract calculi; Intrarenal pressure; Stone-free rate (SFR); Lithotripsy; VISOR; Vortex intelligence Stone Optimized Removal(VISOR）

Outcome Measures

Primary Outcomes (1)

• Immediate Postoperative Stone-Free Rate (SFR):

  Stone clearance rate within 24 hours after surgery.

  24 hours after surgery

Secondary Outcomes (1)

• Stone-Free Rate at 3 Months Postoperatively

  3 Months Postoperatively

Other Outcomes (7)

• Ureteroscopy Operation Time:

  Juring Operation

• Lithotripsy Time

  Juring operation

• Total Laser Energy

  Juring operation

Study Arms (2)

VISOR

EXPERIMENTAL

Surgery will be performed using the VISOR through a 14Fr UAS

Procedure: VISOR

fURS

ACTIVE COMPARATOR

Surgery will be performed using a standard single-use electronic ureterorenoscope through a 14Fr UAS

Procedure: fURS

Interventions

VISOR PROCEDURE

Surgery will be performed using the VISOR through a 14Fr UAS

VISOR

fURS PROCEDURE

Surgery will be performed using a standard single-use electronic ureterorenoscope through a 14Fr UAS

fURS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

MeSH Terms

Conditions

Nephrolithiasis, Calcium Oxalate; Intraoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Li Fang

CONTACT

+8617757461299; fanyuro@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 18, 2025
• Study Start: September 20, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share