An interventional study of 8.6 Fr single-use fURS (XFGC-FU-660RC) and 6.3 Fr single-use fURS (Hugemed, HU30S) in Urinary Stone, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 0 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 52 is below the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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8.6 Fr single-use fURS (XFGC-FU-660RC) arm received 8.6 Fr single-use fURS
Device: 8.6 Fr single-use fURS (XFGC-FU-660RC)
6.3 Fr single-use fURS (HugeMed, HU30S) arm received 6.3 Fr single-use fURS
Device: 6.3 Fr single-use fURS (Hugemed, HU30S)
Comparative device
Device 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.
Time frame: During the procedure
Ureteral access sheath placement (Yes/No)
Whether a ureteral access sheath is placed during the procedure
Time frame: 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
Time frame: 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
Time frame: During the procedure
Surgical duration
From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body
Time frame: During the procedure
Blood loss
Intraoperative blood loss
Time frame: During the procedure
Indwelling catheter duration
Indwelling catheter duration postoperatively
Time frame: Three days postoperatively
Postoperative hospital stay
Postoperative hospital stay
Time frame: Up to one week postoperatively
Perioperative complications
Pain (e.g. dysuria and lumbar pain), Hematuria, Frequency and urgency of urination, Fever
Time frame: Through study completion, up to two months postoperatively
Stone-free rate at 4 weeks postoperatively
Stone-free status was evaluated at 4-week and defined as a single residual fragment ≤2 mm
Time frame: 4 weeks postoperatively
Started Oct 2024 (actual). Primary completion is estimated for Apr 2025, 6 months after the start.
Of 31 interventional studies with no phase under Urinary Calculi, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 6 months is below that.
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The Children's Hospital of Zhejiang University School of Medicine