Actively Recruiting
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children A Single-center Randomized Controlled Trial
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2024-11-12
52
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the safety and effectiveness of two sizes of single-use digital flexible ureteroscopes (fURS) for treating upper urinary tract stones in children. Because children's ureters are narrower and more curved than adults, the size of the fURS can impact the success and cost of the procedure. The study evaluates whether the smaller 6.3 Fr fURS performs as well as the standard 8.6 Fr fURS, aiming to guide future surgical choices for pediatric urinary stones. The study involves two groups: one treated with the 8.6 Fr single-use fURS (XFGC-FU-660RC) and the other with the 6.3 Fr single-use fURS (HugeMed, HU30S). These devices are sterile, disposable, and designed for flexible endoscopy. The smaller 6.3 Fr fURS is the thinnest of its kind and may reduce the need for ureter dilation or stenting during surgery, potentially lowering risks and costs. Each child will receive one of the two devices during ureteroscopy and laser lithotripsy to remove kidney stones. Participants will be monitored during the procedure for the success rate of the first ureteroscope insertion, the need for ureter dilation or stents, surgery duration, and blood loss. Follow-up includes catheter duration for three days, hospital stay up to one week, and complications tracked for two months. Stone clearance will be checked four weeks after surgery. The trial starts in October 2024 and continues until April 2025, with children under 14 years old eligible to participate.
CONDITIONS
Brief Title
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for ureteroscopy and laser lithotripsy for kidney stones sized 5 mm to 20 mm
- Total stone burden should not exceed 20 mm if multiple stones are present
- Children younger than 14 years old
- Informed consent signed by parents for children under 8 years
- Informed consent signed by both parents and child for children 8 years or older
You will not qualify if you...
- Children with uncontrolled urinary tract infections or blood clotting disorders
- Children with severe kidney failure, solitary kidney, nephrocalcinosis, or other serious medical conditions
- Children who refuse to participate
- Any condition that makes participation unsuitable as judged by the investigator
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 - During the procedure
Participants undergo treatment with either the 6.3 Fr or 8.6 Fr single-use flexible ureteroscopes to remove upper urinary tract stones.
1 visit (in-person procedure)
Duration - Up to 2 months postoperatively
Participants are monitored for recovery including catheter duration, hospital stay, and perioperative complications.
Approximately 3 visits postoperatively
Duration - 4 weeks postoperatively
Participants are assessed for stone-free status and any further complications at 4 weeks postoperatively.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310052
Actively Recruiting
Research Team
A
Aimei Ma
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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