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RecruitingNCT07360353FURSUpdated Jan 27, 2026

Comparison Between Different Types of Flexible Ureteroscopes

An interventional study of LithoVue™ (Boston Scientific Corporation) and WiScope® (OTU Medical Inc. (Silicon Valley, USA)) in Renal Calculi and Nephrolithiasis, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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).

Read the 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).

02

Conditions studied

  • Renal Calculi
  • Nephrolithiasis

Keywords

  • Flexible ureteroscopy
  • Single-use flexible ureteroscope
  • Renal stones
03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    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: LithoVue™ (Boston Scientific Corporation)

  • Active comparator
    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: WiScope® (OTU Medical Inc. (Silicon Valley, USA))

  • Active comparator
    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.

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

Interventions

  • DeviceLithoVue™ (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.

  • DeviceWiScope® (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.

  • DeviceSingle-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.

05

What researchers measure

Primary outcomes

  1. Cost-effectiveness of single-use flexible ureteroscopes

    Comparison of total procedural cost and stone-free rate among three single-use flexible ureteroscopes used in retrograde intrarenal surgery (RIRS).

    Time frame: 4 weeks postoperatively

Secondary outcomes

  1. Operative Time and Postoperative Complications

    Incidence of postoperative complications within the postoperative period.

    Time frame: up to 4 weeks postoperatively

06

Study locations

1 of 1 sites recruiting
  • Ain Shams University hospital
    Cairo, 11566, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07360353
Lead sponsor
Ain Shams University
Responsible party
Hesham Elsayed Mohammed (Principal Investigator, Ain Shams University) — Principal investigator
First posted
Jan 22, 2026
Start date
Jan 25, 2026
Primary completion
Aug 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Jan 27, 2026

Study contacts

Hesham E Khayrallah, Resident
Contact
heshamkhayrallah111@gmail.com
+201016704043
Ashraf M Satour, Lecturer
Contact
+201050505463
Hesham E Khayrallah, Resident
principal investigator · Ain Shams University

Oversight

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

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