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NCT Number: NCT06987760

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

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

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Key information

Conditions

Ureter Injury Efficacy, Self Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urolithiasis Urolithiasis; Lower Urinary Tract Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

2.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.

Exclusion criteria

  • 1.Patients with a history of ureteral stenosis or who have undergone open or laparoscopic ureteral or renal lithotomy.

2.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.

6.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.

8.Patients with renal anatomic malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney.

Treatment and study plan

flexible ureteroscope urolithiasis

Procedure

Using flexible ureteroscope combine with urethral access sheath to treatment urolithiasis

Primary outcomes

  1. Success rate of ureteral access sheath insertion

    Time frame: From enrollment to completion of surgery

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

Secondary outcomes

  1. The condition of ureter injury

    Time frame: 24 hours

    The ureter was observed at exit of the ureteroscope and graded according to Traxer's proposed grading system.

  2. Stone clearance rate

    Time frame: up to 8 weeks.

    Residual stones less than 4 mm are considered to be free of residual stones.

  3. Operation time

    Time frame: 24 hours

    The duration of the operation from start to finish.

  4. The incidence of surgical complications

    Time frame: 7 days

    The occurrence of postoperative fever, urogenic sepsis and septic shock

Study contacts

Contact information is provided by the study sponsor or research team.

Li Fang

CONTACT

[email protected]

+86-13586681743

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Collaborators

  • The Central Hospital of Lishui City
  • The First People's Hospital of Fuyang District, Hangzhou City

Registry information

Official study title

Comparing Different Diameter fURSs With Similar RESDs for the Treatment of Upper Urinary Tract Stones - A Randomized Controlled Multi-center Clinical Trials

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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