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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Children's hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Aimei Ma
maaimei@zju.edu.cn
+86 15888864134
Time Frame
Start Date: 2024-10-08
Estimated Completion Date: 2025-04-08
Participants
Target number of participants: 52
Treatments
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
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
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine

This content was sourced from clinicaltrials.gov