Actively Recruiting
Comparing Different Diameter Flexible Ureteroscopes With Similar Ureteral Access Sheaths for Treating Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trial
Led by Ningbo No. 1 Hospital · Updated on 2025-05-23
206
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
Ningbo No. 1 Hospital
Lead Sponsor
T
The First People's Hospital of Fuyang District, Hangzhou City
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating and comparing the efficiency, effectiveness, and safety of flexible ureteroscope (fURS) lithotripsy using similar ureteral access sheaths (RESDs) for treating upper urinary tract stones. The study focuses on patients with kidney or upper ureteral stones less than 3 cm in total size and aims to assess different diameter flexible ureteroscopes combined with access sheaths to improve surgical outcomes. The study compares two groups: one uses a 7.5Fr disposable electronic flexible ureteroscope combined with a 10Fr deflectable ureteral access sheath, and the other uses a 9.0Fr disposable electronic flexible ureteroscope combined with a 12Fr access sheath. Both groups receive ureteral soft lens holmium laser lithotripsy. This is a randomized, single-masked, multi-center clinical trial conducted by Ningbo No. 1 Hospital. Participants will be monitored from enrollment through surgery completion to measure the success rate of ureteral access sheath insertion. Additional assessments include ureter injury condition within 24 hours, stone clearance rate up to 8 weeks post-surgery, operation time within 24 hours, and surgical complications within 7 days. The total study duration for each participant includes these follow-up periods to ensure comprehensive safety and effectiveness evaluations.
CONDITIONS
Brief Title
Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with kidney stones or upper ureteral stones with a total diameter less than 3 cm selected for ureteral soft lens holmium laser lithotripsy
- Age between 18 and 80 years, any gender
- No mental illness or language dysfunction, able to understand the study and provide informed consent
You will not qualify if you...
- History of ureteral narrowing or prior open or laparoscopic ureteral or kidney stone surgery
- Fever within one week before surgery
- Pregnant women or menstruating patients
- Combined systemic diseases or inability to tolerate anesthesia
- Simultaneous surgery for bilateral upper urinary tract stones
- Ureteral stent placement before surgery
- Severe hydronephrosis with renal collecting system separation greater than 4 cm
- Renal anatomical malformations such as polycystic kidney, horseshoe kidney, or ectopic kidney
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus 24 hours
Participants undergo flexible ureteroscope lithotripsy using different diameter ureteroscopes combined with ureteral access sheaths, followed by immediate post-operative monitoring.
1 surgery visit and 1 post-operative visit within 24 hours
Duration - Up to 8 weeks
Participants are monitored for surgical complications and stone clearance after the procedure.
Approximately 3 follow-up visits over 8 weeks
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
Research Team
L
Li Fang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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