Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children

Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children: A Single-center Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Stone
• Intervention / Treatment: Device: 8.6 Fr single-use fURS (XFGC-FU-660RC); Device: 6.3 Fr single-use fURS (Hugemed, HU30S)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aimei Ma; Phone Number: +86 15888864134; Email: maaimei@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310052
      • Recruiting
      • Children's Hospital, Zhejiang University School of Medicine
      • Contact: Hongbo Liu; Phone Number: +86 19329110160; Email: 19329110160@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 8.6 Fr single-use fURS (XFGC-FU-660RC); 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); Comparative device
Experimental: 6.3 Fr single-use fURS (HugeMed, HU30S); 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); Device being tested

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: Hongbo Liu, Children's Hospital, Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): April 8, 2025
• Study Completion (Estimated): April 8, 2025

Study Registration Dates

• First Submitted: September 28, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: November 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Children; Urinary Stone; Flexible Ureteroscopy
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: 2024-IRB-0310-P-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No