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Recruiting NCT07360353

Comparison Between Different Types of Flexible Ureteroscopes

No phase Interventional Renal Calculi Nephrolithiasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LithoVue™ (Boston Scientific Corporation), WiScope® (OTU Medical Inc. (Silicon Valley, USA)), Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.).
Who it may be relevant to
Registry conditions: Renal Calculi, Nephrolithiasis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Comparative Study of Performance and Cost-effectiveness of Three Different Single-Use Flexible Ureteroscopes in the Management of Renal Stones: A Randomized Clinical Trial

Overview

The current study aims to compare the performance of three distinct single-use digital flexible ureteroscope types in terms of cost-effectiveness, postoperative complications, operating time, and stone-free rates (SFRs).

Detailed description

Retrograde intrarenal surgery (RIRS) is the preferred treatment modality for renal stones measuring less than 20 millimeters (mm). Several types of flexible ureteroscopes are currently available on the market from different manufacturers. However, there is a shortage of comparative studies evaluating the performance of different single-use flexible ureteroscopes.

This study aims to compare the performance of three different single-use digital flexible ureteroscopes in terms of cost-effectiveness, postoperative complications, operative time, and stone-free rates (SFRs).

Interventions

  • Device LithoVue™ (Boston Scientific Corporation)
    Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope.
  • Device WiScope® (OTU Medical Inc. (Silicon Valley, USA))
    Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope single-use digital flexible ureteroscope.
  • Device Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)
    Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the single-use digital flexible ureterorenoscope manufactured by Scivita Medical Technology Co., Ltd.

Primary outcome measures

  • Cost-effectiveness of single-use flexible ureteroscopes [Time frame: 4 weeks postoperatively]
Secondary outcome measures (1)
  • Operative Time and Postoperative Complications [Time frame: up to 4 weeks postoperatively]

Eligibility criteria

Inclusion criteria

  • Patients aged 18 to 60 years.
  • Presence of renal stones measuring less than 20 millimeters (mm).

Exclusion criteria

  • Renal stones larger than 20 millimeters (mm).
  • Uncontrolled bleeding disorders or coagulopathies.
  • Active urinary tract infection.
  • Renal failure.
  • Uncontrolled diabetes mellitus, hypertension, or hepatic dysfunction.
  • Pregnancy.
  • Abnormal urinary tract anatomy or known ureteric stricture.
  • History of previous open ureteric surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Ain Shams University hospital — Cairo

Identifiers

NCT: NCT07360353 · FMASU MS 788/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗