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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8.6 Fr single-use fURS (XFGC-FU-660RC) | Active Comparator | 8.6 Fr single-use fURS (XFGC-FU-660RC) arm received 8.6 Fr single-use fURS |
|
| 6.3 Fr single-use fURS (HugeMed, HU30S) | Experimental | 6.3 Fr single-use fURS (HugeMed, HU30S) arm received 6.3 Fr single-use fURS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 8.6 Fr single-use fURS (XFGC-FU-660RC) | Device | Comparative device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Ureteral access sheath placement (Yes/No) | Whether a ureteral access sheath is placed during the procedure | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aimei Ma | Contact | +86 15888864134 | maaimei@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongbo Liu | The Children's Hospital of Zhejiang University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41876909 | Derived | Hu Q, Liu H, Lin C, Ru W, Xu Z, Hu L, Xu Z, He K, Liu L, Yan X. Efficacy and safety of 6.3-Fr versus 8.6-Fr disposable digital flexible ureteroscopes for pediatric upper urinary tract stones </= 2 cm: a randomized controlled trial. World J Urol. 2026 Mar 24;44(1):259. doi: 10.1007/s00345-026-06352-x. |
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| 6.3 Fr single-use fURS (Hugemed, HU30S) | Device | Device being tested |
|
| 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 | During the procedure |
| Surgical duration | From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body | During the procedure |
| Blood loss | Intraoperative blood loss | During the procedure |
| Indwelling catheter duration | Indwelling catheter duration postoperatively | Three days postoperatively |
| Postoperative hospital stay | Postoperative hospital stay | Up to one week postoperatively |
| Perioperative complications | Pain (e.g. dysuria and lumbar pain), Hematuria, Frequency and urgency of urination, Fever | 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 | 4 weeks postoperatively |
| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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