Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones

NCT06987760 | Recruiting DMC

• 1 other identifier: MNWK202401
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the Efficiency, Effectiveness, and Safety of fURS lithotripsy with Similar RESDs in the Treatment of Upper Urinary Tract Stones.

Conditions

Ureter Injury; Urolithiasis; Lower Urinary Tract; Efficacy, Self

Keywords

Urolithiasis; Ratio of Endoscope-Sheath Diameter; Flexible ureteroscope

Outcome Measures

Primary Outcomes (1)

• Success rate of ureteral access sheath insertion

  Proportion of successful ureteral implantation, success rate = number of successful cases/total number of cases

  From enrollment to completion of surgery

Secondary Outcomes (4)

• The condition of ureter injury

  24 hours

• Stone clearance rate

  up to 8 weeks.

• Operation time

  24 hours

• The incidence of surgical complications

  7 days

Study Arms (2)

7.5Fr fURS and 10Fr UAS

EXPERIMENTAL

7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.

Procedure: flexible ureteroscope urolithiasis

9.0Fr fURS and 12Fr UAS

ACTIVE COMPARATOR

9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.

Procedure: flexible ureteroscope urolithiasis

Interventions

flexible ureteroscope urolithiasis PROCEDURE

Using flexible ureteroscope combine with urethral access sheath to treatment urolithiasis

7.5Fr fURS and 10Fr UAS; 9.0Fr fURS and 12Fr UAS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.Patients with kidney stones or upper ureteral stones with a cumulative diameter of less than 3 cm are selected for ureteral soft lens holmium laser lithotripsy.
• Age 18 to 80 years old, gender unlimited. 3.The subjects have no mental illness or language dysfunction, can understand the situation of the study and can sign informed consent.

You may not qualify if:

• Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.
• Patients with fever one week before surgery 3.Pregnant women and menstruating patients. 4.Patients with combined systemic disease or inability to tolerate anesthesia. 5.Patients undergoing simultaneous surgery for bilateral upper urinary tract stones.
• Patients with ureteral stent indwelling before surgery. 7.In patients with severe hydronephrosis, the separation of the renal collecting system is greater than 4 cm.
• Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead
• The First People's Hospital of Fuyang District, Hangzhou City: collaborator
• The Central Hospital of Lishui City: collaborator

Study Sites (1)

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Li Fang

CONTACT

+86-13586681743; fanyruo@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: May 23, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 23, 2025

Record last verified: 2025-02

Locations

CN (1)