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NCT Number: NCT06628765

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

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.

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Key information

Age range

0 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location status: Recruiting

Location contact

Hongbo Liu

CONTACT

[email protected]

+86 19329110160

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

8.6 Fr single-use fURS (XFGC-FU-660RC)

Device

Comparative device

6.3 Fr single-use fURS (Hugemed, HU30S)

Device

Device being tested

Primary outcomes

  1. The success rate of the first fURS insertion

    Time frame: During the procedure

    The first insertion of fURS is successful without the need for balloon dilation or passive dilation with a stent.

Secondary outcomes

  1. Ureteral access sheath placement (Yes/No)

    Time frame: During the procedure

    Whether a ureteral access sheath is placed during the procedure

  2. Balloon dilation rate

    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

  3. Pre-placement rate of double-J stents

    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

  4. Surgical duration

    Time frame: During the procedure

    From the initiation of fURS insertion to the completion of lithotripsy, the fURS is withdrawn from the body

  5. Blood loss

    Time frame: During the procedure

    Intraoperative blood loss

  6. Indwelling catheter duration

    Time frame: Three days postoperatively

    Indwelling catheter duration postoperatively

  7. Postoperative hospital stay

    Time frame: Up to one week postoperatively

    Postoperative hospital stay

  8. Perioperative complications

    Time frame: Through study completion, up to two months postoperatively

    Pain (e.g. dysuria and lumbar pain), Hematuria, Frequency and urgency of urination, Fever

  9. Stone-free rate at 4 weeks postoperatively

    Time frame: 4 weeks postoperatively

    Stone-free status was evaluated at 4-week and defined as a single residual fragment ≤2 mm

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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