The single-use digital flexible Ureteroscopy (fURS) is commonly used for the treatment of upper urinary tract stones. The size of the outer diameter of the fURS can affect the safety, efficacy, and medical costs of the treatment. Particularly for children, their ureters are thinner and more tortuous compared to adults, which places higher demands on medical devices. The investigators are interested in determining if the performance of the two different sizes of fURS (6.3 Fr vs. 8.6 Fr) are equivalent. This study will have guiding significance for the selection of upper urinary tract stones surgery in children in the future.
Patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple stones present, the total stone burden in cross section should not exceed 20 mm)
Patients < 14 years
For children younger than 8 years old, the informed consent form is signed by the parents; for children older than 8 years old, the informed consent form is signed by both the parents and the child themselves.
Children with uncontrolled urinary tract infections or coagulation disorders and other contraindications for surgery before the operation.
Children with severe renal insufficiency, anatomical or functional solitary kidney, known nephrocalcinosis, and other significant comorbidities that are not suitable for participating in the study.
Children who refuse to participate in this study.
Any other reason that in the opinion of the investigator would make the participant unsuitable for enrollment in the study.
Parallel
8.6 Fr single-use fURS (XFGC-FU-660RC)
DeviceComparative device
6.3 Fr single-use fURS (Hugemed, HU30S)
DeviceDevice being tested
The success rate of the first fURS insertion
The first insertion of fURS is successful without the need for balloon dilation or passive dilation with a stent.
Ureteral access sheath placement (Yes/No)
Whether a ureteral access sheath is placed during the procedure
Balloon dilation rate
Due to difficulty in passing the fURS through the ureter, balloon dilation of the ureter is performed during the procedure
Pre-placement rate of double-J stents
Due to difficulty in passing the fURS through the ureter, the double-J stent is placed during the surgery to passively dilate the ureter, facilitating a second-stage fURS procedure
Surgical duration
From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body
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