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

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Oct 3, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring two types of single-use flexible ureteroscopes (fURS) to treat urinary stones in children. These tools help doctors remove stones from the upper urinary tract, and the trial is comparing two different sizes of the ureteroscope to see if they work equally well. This is important because children's ureters (the tubes that carry urine from the kidneys to the bladder) are smaller and more curved than adults', which means the right tools are crucial for safe and effective treatment.

To participate in this study, children must be under 14 years old and scheduled for surgery to remove kidney stones that are between 5 mm and 20 mm in size. Parents or guardians will provide consent for children younger than 8, while older children will help decide about their participation. However, children with certain health issues, like uncontrolled infections or severe kidney problems, cannot join. If enrolled, participants can expect to receive treatment using one of the two types of ureteroscopes, helping researchers understand which might be better for future surgeries in kids.

Gender

ALL

Eligibility criteria

• 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.