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

N

Ningbo No. 1 Hospital

Status

Enrolling

Conditions

Ureter Injury
Efficacy, Self
Urolithiasis; Lower Urinary Tract

Treatments

Procedure: flexible ureteroscope urolithiasis

Study type

Interventional

Funder types

Other

Identifiers

NCT06987760
MNWK202401

Details and patient eligibility

About

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

Full description

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

Enrollment

206 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

206 participants in 2 patient groups

7.5Fr fURS and 10Fr UAS
Experimental group
Description:
7.5Fr disposable electronic flexible ureteroscope combine with 10Fr distally deflectable ureteral access sheath.
Treatment:
Procedure: flexible ureteroscope urolithiasis
9.0Fr fURS and 12Fr UAS
Active Comparator group
Description:
9.0Fr disposable electronic flexible ureteroscope combine with 12Fr distally deflectable ureteral access sheath.
Treatment:
Procedure: flexible ureteroscope urolithiasis

Trial contacts and locations

1

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Central trial contact

Li Fang

Data sourced from clinicaltrials.gov

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