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

NCT ID: NCT06628765

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2025-04-08

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.

Detailed Description

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.

Conditions

Urinary Stone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Comparative device

6.3 Fr single-use fURS (HugeMed, HU30S)

6.3 Fr single-use fURS (HugeMed, HU30S) arm received 6.3 Fr single-use fURS

Group Type: EXPERIMENTAL

6.3 Fr single-use fURS (Hugemed, HU30S)

Intervention Type: DEVICE

Device being tested

Interventions

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

Comparative device

Intervention Type: DEVICE

6.3 Fr single-use fURS (Hugemed, HU30S)

Device being tested

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Hongbo Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongbo Liu

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Zhejiang University School of Medicine

Locations

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Aimei Ma

Role: CONTACT

maaimei@zju.edu.cn

+86 15888864134

Facility Contacts

Hongbo Liu

Role: primary

19329110160@zju.edu.cn

+86 19329110160

Other Identifiers

2024-IRB-0310-P-01

Identifier Type: -

Identifier Source: org_study_id