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RecruitingNCT06987760Updated May 23, 2025

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

An interventional study of flexible ureteroscope urolithiasis in Ureter Injury, Urolithiasis; Lower Urinary Tract and Efficacy, Self, sponsored by Ningbo No. 1 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
206
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

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

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Keywords

  • Urolithiasis
  • Ratio of Endoscope-Sheath Diameter
  • Flexible ureteroscope
03

In context

Urolithiasis

253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.

This study's planned enrollment of 206 is above the median of 100 across 182 interventional studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 59 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
206 participants (estimated)

Study arms

  • Experimental
    7.5Fr fURS and 10Fr UAS

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

    Procedure: flexible ureteroscope urolithiasis

  • Active comparator
    9.0Fr fURS and 12Fr UAS

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

    Procedure: flexible ureteroscope urolithiasis

Interventions

  • Procedureflexible ureteroscope urolithiasis

    Using flexible ureteroscope combine with urethral access sheath to treatment urolithiasis

06

What researchers measure

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

    Time frame: From enrollment to completion of surgery

Secondary outcomes

  1. The condition of ureter injury

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

    Time frame: 24 hours

  2. Stone clearance rate

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

    Time frame: up to 8 weeks.

  3. Operation time

    The duration of the operation from start to finish.

    Time frame: 24 hours

  4. The incidence of surgical complications

    The occurrence of postoperative fever, urogenic sepsis and septic shock

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06987760
Lead sponsor
Ningbo No. 1 Hospital
Collaborators
The First People's Hospital of Fuyang District, Hangzhou City, The Central Hospital of Lishui City
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Mar 19, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 23, 2025

Study contacts

Li Fang
Contact
fanyruo@126.com
+86-13586681743

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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