Renal CalculiFURSNCT07360353
Comparison Between Different Types of Flexible Ureteroscopes
A study testing LithoVue™ (Boston Scientific Corporation), WiScope® (OTU Medical Inc. (Silicon Valley, USA)) and Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) in people with Renal Calculi and Nephrolithiasis, run by Ain Shams University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Calculi, Nephrolithiasis
- What is being tested?
- LithoVue™ (Boston Scientific Corporation), WiScope® (OTU Medical Inc. (Silicon Valley, USA)) and Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 to 60 years.
- Presence of renal stones measuring less than 20 millimeters (mm).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ashraf M Satour, Lecturer contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University hospital
Cairo, 11566
Hesham E Khayrallah, Resident, +201016704043, heshamkhayrallah111@gmail.com
About this study
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
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).
- Conditions
- Renal Calculi, Nephrolithiasis
- Being tested
- LithoVue™ (Boston Scientific Corporation), WiScope® (OTU Medical Inc. (Silicon Valley, USA)), Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)
- Keywords
- Flexible ureteroscopy, Single-use flexible ureteroscope, Renal stones
- Medical subject headings
- Kidney Calculi, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithoVue™ (Boston Scientific Corporation)Device
Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope.
WiScope® (OTU Medical Inc. (Silicon Valley, USA))Device
Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope single-use digital flexible ureteroscope.
Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| LithoVue™ (Boston Scientific Corporation) | Active comparator | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope. Receives: Device: LithoVue™ (Boston Scientific Corporation) |
| WiScope® (OTU Medical Inc. (Silicon Valley, USA)) | Active comparator | Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope® single-use digital flexible ureteroscope. Receives: Device: WiScope® (OTU Medical Inc. (Silicon Valley, USA)) |
| Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) | Active comparator | 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. Receives: Device: Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks postoperatively
Secondary outcomes (1)
Operative Time and Postoperative Complications
Incidence of postoperative complications within the postoperative period.
Measured: up to 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start25 Jan 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Elsayed Mohammed, Ain Shams University
- Investigators
- Hesham E Khayrallah, Resident, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360353
- Sponsor's protocol ID
- FMASU MS 788/2025
- Acronym
- FURS
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07360353
- Acronym / sponsor ID
- FURS / FMASU MS 788/2025
- Conditions
- Renal Calculi, Nephrolithiasis
- Keywords
- Flexible ureteroscopy, Single-use flexible ureteroscope, Renal stones
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LithoVue™ (Boston Scientific Corporation) | Active comparator | 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. |
| WiScope® (OTU Medical Inc. (Silicon Valley, USA)) | Active comparator | 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. |
| Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) | Active comparator | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 60 years.
- Presence of renal stones measuring less than 20 millimeters (mm).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) |
| 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)) |
| 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.) |
Primary outcome
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).
1 secondary outcome
Operative Time and Postoperative Complications
Time frame: up to 4 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Renal Calculi
Recruiting
Randomized Controlled Trial of Miniaturized Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheaths Versus Conventional Sheaths for Treatment of Nephrolithiasis
Kidney Stone
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
RecruitingPhase 3
Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention
Kidney Stone, Nephrolithiasis
RecruitingObservational study
Renal Stone Treatment Global Registry
Urolithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashraf M Satour, Lecturer contact
Hesham E Khayrallah, Resident principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LithoVue™ (Boston Scientific Corporation), WiScope® (OTU Medical Inc. (Silicon Valley, USA)) and Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) in people with Renal Calculi and Nephrolithiasis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hesham E Khayrallah, Resident (+201016704043, heshamkhayrallah111@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness of single-use flexible ureteroscopes (time frame: 4 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.