LithoVue Elite Ureteroscope for Kidney Stones

(ELITE Trial)

Overseen By Jane Ledesma

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Bilateral stone treatment, Anatomical abnormalities, Coagulopathy, Urinary diversions, Pregnancy, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Procedure

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how real-time kidney pressure information influences surgeons' decisions during kidney stone removal procedures. Participants will be divided into two groups: one where surgeons have access to this real-time pressure data and another where they do not. The study seeks individuals undergoing flexible ureteroscopy (a procedure using a thin tube with a camera) for kidney stones larger than 2 cm. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the LithoVue Elite ureteroscope is safe for use in ureteroscopy?

Research has shown that the LithoVue Elite Ureteroscope, which monitors kidney pressure in real-time, aims to make kidney stone procedures safer. This technology allows doctors to see kidney pressure immediately, helping to prevent complications.

Studies have found that real-time pressure monitoring can reduce the risks of infections and pain during ureteroscopy. Although this feature is new, similar ureteroscopes have been used safely in many procedures.

While detailed safety data for this specific use is not yet available, the regular use of similar devices suggests it is likely safe. Prospective trial participants may find comfort in knowing that this technology might enhance safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of real-time intrarenal pressure (IRP) monitoring during ureteroscopy (URS) for kidney stones, a common procedure used to remove stones. Unlike standard URS, which does not provide surgeons with immediate pressure feedback, this method allows them to see IRP in real-time using the LithoVue Elite™ ureteroscope. This visibility has the potential to improve surgical precision and patient outcomes by preventing complications associated with high intrarenal pressure, such as kidney damage or infection. By providing immediate pressure data, surgeons can make more informed decisions during the procedure, potentially leading to safer and more effective treatments for kidney stones.

What evidence suggests that intrarenal pressure monitoring is effective for kidney stones?

Research has shown that the LithoVue Elite ureteroscope, which monitors kidney pressure in real-time, may help reduce infections after kidney stone surgeries. In this trial, one group of participants will undergo ureteroscopy (URS) with real-time intrarenal pressure (IRP) monitoring visible to surgeons, enabling them to adjust techniques to prevent complications. Evidence suggests that monitoring this pressure can improve patient outcomes by potentially reducing pain and infections. Studies have also indicated that this technology might enhance the overall quality of life for patients undergoing ureteroscopy, a procedure to treat kidney stones. This new approach is being further studied to confirm these benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Bristol B Whiles, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing ureteroscopy, a procedure to remove kidney stones. Specific eligibility criteria are not provided, but typically participants would have kidney stones and be suitable candidates for this type of surgery.

Inclusion Criteria

I am over 18 years old.

I am having a procedure to remove stones from my kidney or upper ureter.

My kidney stones are larger than 2 cm in total.

Exclusion Criteria

Immunosuppressed patients

I am having surgery to remove stones from both kidneys at once.

I have a known abnormality in my urinary system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo ureteroscopy with or without real-time intrarenal pressure monitoring using the LithoVue Elite ureteroscope

Procedure

1 visit (in-person)

Follow-up

Participants are monitored for post-operative outcomes, including infection and pain management

30 days

Follow-up visits per standard of care

What Are the Treatments Tested in This Trial?

Interventions

• INTRARENAL PRESSURE MONITORING VISIBLE

Trial Overview The study aims to assess how having real-time intrarenal pressure data affects surgeons' decisions during ureteroscopy using the LithoVue Elite ureteroscope, which has built-in pressure monitoring technology.

How Is the Trial Designed?

Group I: URS WITH INTRARENAL PRESSURE MONITORING VISIBLE Active Control 1 Intervention

In Arm 1, participants will undergo URS with real-time IRP monitoring visible to surgeons using the LithoVue Elite™. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.

Group II: URS WITHOUT INTRARENAL PRESSURE MONITORING VISIBLE Active Control 1 Intervention

In Arm 2, participants will undergo URS LithoVue Elite™ without the real-time IRP monitoring information visible to the surgeon. Participants will be scheduled to undergo URS per standard of care. All follow-up visits will be scheduled per standard of care.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Published Research Related to This Trial

The LithoVue single-use digital flexible ureteroscope demonstrated comparable maneuverability and visibility to conventional ureteroscopes in a study involving three surgeons testing four renal units in human cadavers.

While all ureteroscopes required a ureteral access sheath for effective kidney access, LithoVue was preferred for maneuverability in most procedures, indicating its potential utility in clinical settings, though further studies in live patients are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of New Single-Use Digital Flexible Ureteroscope Versus Nondisposable Fiber Optic and Digital Ureteroscope in a Cadaveric Model. Proietti, S., Dragos, L., Molina, W., et al.[2022]

The LithoVue™ flexible ureteroscope demonstrated good image quality and maneuverability during a study of 40 procedures, with 65% of cases rated as having 'very good' image quality and 77.5% rated as 'very good' for maneuverability.

Despite its effectiveness, there were two instances (5%) of the LithoVue™ breaking during surgery, indicating a need for further evaluation of its durability and overall surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. Doizi, S., Kamphuis, G., Giusti, G., et al.[2022]

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/products/lithovue-elite.html

LithoVue™ Elite - Next-Gen Ureteroscope The LithoVue Elite Ureteroscope with IRP monitoring displays accurate, real-time, second-by-second, intrarenal pressure data directly on your current operating ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04900688

Prospective Evaluation of the LithoVue Elite Ureteroscope We will evaluate the impact of intra renal pressure on pain, quality of life and possible infectious complications. Detailed Description. This is a single arm ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12112042/

Real-Time Measurement of Intrarenal Pressure Using ... LithoVue™ Elite (LVE) is the first commercially available ureteroscope (URS) capable of providing real-time IRP measurements. Conventionally, ...

4. trialx.com trialx.com/clinical-trials/listings/301094/evaluation-of-the-lithovue-elite-ureteroscope-with-intra-renal-pressure-monitoring-technology-examination-of-surgeon-behavior-and-post-operative-outcomes/

Evaluation of the LithoVue Elite Ureteroscope With Intra ... The study is designed to evaluate urologists' behavior during ureteroscopic stone treatment with and without intra-renal pressure monitoring.

5. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2025.2557403

Post-operative infection with a single-use ureteroscope ... Use of LVE with pressure monitoring may reduce post-operative infection and healthcare burden of kidney stones. KEYWORDS: Infection · intrarenal pressure ...

6. urologytimes.com urologytimes.com/view/real-time-irp-monitoring-may-redefine-safety-and-scope-of-flexible-ureteroscopy

Real-time IRP monitoring may redefine safety and scope of ... LithoVue Elite's real-time IRP monitoring may expand ureteroscopy to larger stones, improving patient outcomes by reducing complications like ...