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

NCT06628765 | Recruiting

• 1 other identifier: 2024-IRB-0310-P-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Stone

Keywords

Urinary Stone; Flexible Ureteroscopy; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Ureteral access sheath placement (Yes/No)

  During the procedure

• Balloon dilation rate

  During the procedure

• Pre-placement rate of double-J stents

  During the procedure

• Surgical duration

  During the procedure

• Blood loss

  During the procedure

Study Arms (2)

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

ACTIVE COMPARATOR

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)

6.3 Fr single-use fURS (HugeMed, HU30S)

EXPERIMENTAL

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)

Interventions

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

Comparative device

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

6.3 Fr single-use fURS (Hugemed, HU30S) DEVICE

Device being tested

6.3 Fr single-use fURS (HugeMed, HU30S)

Eligibility Criteria

• Age: 0 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hongbo Liu

  Children's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimei Ma

CONTACT

+86 15888864134; maaimei@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 8, 2024
• Study Start: October 8, 2024
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (1)