Comparison Between Different Types of Flexible Ureteroscopes (FURS)

January 25, 2026 updated by: Hesham Elsayed Mohammed, Ain Shams University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ashraf M Satour, Lecturer
  • Phone Number: +201050505463

Study Locations

  • Egypt
      • Cairo, Egypt, 11566
        • Recruiting
        • Ain Shams University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of single-use flexible ureteroscopes
Time Frame: 4 weeks postoperatively
Comparison of total procedural cost and stone-free rate among three single-use flexible ureteroscopes used in retrograde intrarenal surgery (RIRS).
4 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative Time and Postoperative Complications
Time Frame: up to 4 weeks postoperatively
Incidence of postoperative complications within the postoperative period.
up to 4 weeks postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Hesham E Khayrallah, Resident, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MS 788/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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