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

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the influence of real-time intrarenal pressure measurement availability on surgeons' behavior during ureteroscopy while using the ureteroscope LithoVue Elite.

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 data supports the effectiveness of the treatment LithoVue Elite Ureteroscope for Kidney Stones?

The LithoVue Elite ureteroscope, which measures pressure inside the kidney, has been shown to accurately monitor intrarenal pressure, which is important for making clinical decisions during kidney stone procedures. Studies indicate that it can help manage pressure effectively, potentially reducing complications during surgery. ^{1 2 3 4 5}

Is the LithoVue Elite Ureteroscope safe for use in humans?

The LithoVue Elite Ureteroscope has been used in human studies to measure intrarenal pressure during procedures, and no specific safety concerns were reported in these studies. It is a single-use device, which helps reduce the risk of infection transmission. ^{1 2 3 5 6}

How does the LithoVue Elite Ureteroscope treatment for kidney stones differ from other treatments?

The LithoVue Elite Ureteroscope is unique because it is the first commercial ureteroscope that can measure intrarenal pressure (pressure inside the kidney) during the procedure, which helps in making better clinical decisions. This feature is not available in traditional ureteroscopes, making it a novel tool for managing kidney stones. ^{1 2 3 5 6}

Research Team

Bristol B Whiles, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

I have a known abnormality in my urinary system.

Immunosuppressed patients

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Retrospective first-in-human use of the LithoVue™ Elite ureteroscope to measure intrarenal pressure. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intrarenal Pressure Measured Using a Novel Flexible Ureteroscope with Pressure Sensing Capabilities: A Study of the Effects of Ureteral Access Sheath, Irrigation, and Working Channel Accessories. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Single-Center Prospective Comparative Study of Two Single-Use Flexible Ureteroscopes: LithoVue (Boston Scientific, USA) and Uscope PU3022a (Zhuhai Pusen, China). [2021]

4. Sweden pubmed.ncbi.nlm.nih.gov

Intrarenal pressures during percutaneous nephrolithotomy: a porcine kidney model. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparison of New Single-Use Digital Flexible Ureteroscope Versus Nondisposable Fiber Optic and Digital Ureteroscope in a Cadaveric Model. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. [2022]