Comparison Between Different Types of Flexible Ureteroscopes (FURS)

Ain Shams University

Status: Enrolling

Conditions: Renal Calculi; Nephrolithiasis

Treatments: Device: WiScope® (OTU Medical Inc. (Silicon Valley, USA)); Device: LithoVue™ (Boston Scientific Corporation); Device: Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)

Study type: Interventional

Funder types: Other

Identifiers

NCT07360353

FMASU MS 788/2025

Details and patient eligibility

About

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).

Full 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).

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups

LithoVue™ (Boston Scientific Corporation)

Active Comparator group

Description:

Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope.

Treatment:

Device: LithoVue™ (Boston Scientific Corporation)

WiScope® (OTU Medical Inc. (Silicon Valley, USA))

Active Comparator group

Description:

Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope® single-use digital flexible ureteroscope.

Treatment:

Device: WiScope® (OTU Medical Inc. (Silicon Valley, USA))

Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)

Active Comparator group

Description:

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.

Treatment:

Device: Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)