Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
Location status: Recruiting
NCT Number: NCT06628765
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.
Interested in participating?
Request Info0 year–14 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310052, China
Location status: Recruiting
The single-use digital fURS is a sterile, disposable, flexible endoscope. Compared to traditional reusable digital flexible endoscopes, single-use digital fURS has lower maintenance costs, is easier to operate, and effectively avoids cross-infection between patients. With technological advancements, the size of single-use digital fURS has become increasingly slim, making them particularly suitable for children with narrow and tortuous ureters who suffered urinary stones. Currently, the single-use digital fURS used in our unit has an outer diameter of 8.6Fr. For younger children, the success rate of the first insertion of the fURS is still relatively low. When the fURS cannot pass through the ureter, it is necessary to actively dilate the ureter with a balloon in one stage, or passively dilate it with a urethral stent during the procedure to facilitate a second-stage fURS procedure. This not only increases the risk of ureteral injury but also incurs additional medical expenses. Recently, HugeMed Company has launched a single-use digital fURS with an outer diameter of 6.3 Fr, which is currently the thinnest single-use fURS in the world, and its effectiveness and safety have been preliminarily verified in clinical practice. The purpose of this study is to compare the safety and efficacy of the 6.3 Fr fURS (HU30S) and the 8.6 Fr fURS (XFGC-FU-660RC) in the clinical treatment of upper urinary tract stones in children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparative device
Device being tested
Time frame: During the procedure
The first insertion of fURS is successful without the need for balloon dilation or passive dilation with a stent.
Time frame: During the procedure
Whether a ureteral access sheath is placed during the procedure
Time frame: During the procedure
Due to difficulty in passing the fURS through the ureter, balloon dilation of the ureter is performed during the procedure
Time frame: During the procedure
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
Time frame: During the procedure
From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body
Time frame: During the procedure
Intraoperative blood loss
Time frame: Three days postoperatively
Indwelling catheter duration postoperatively
Time frame: Up to one week postoperatively
Postoperative hospital stay
Time frame: Through study completion, up to two months postoperatively
Pain (e.g. dysuria and lumbar pain), Hematuria, Frequency and urgency of urination, Fever
Time frame: 4 weeks postoperatively
Stone-free status was evaluated at 4-week and defined as a single residual fragment ≤2 mm
Contact information is provided by the study sponsor or research team.
The Children's Hospital of Zhejiang University School of Medicine
Other
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children: A Single-center Randomized Controlled Trial
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