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

RecruitingNAAges 0 Years - 14 YearsAllThe Children's Hospital of Zhejiang University Scโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • 8.6 Fr single-use fURS (XFGC-FU-660RC)
  • 6.3 Fr single-use fURS (Hugemed, HU30S)
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Where

1 site
Children's hospital, Zhejiang University School of Medicine
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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