80 Participants Needed

LithoVue Elite Ureteroscope for Kidney Stones

(ELITE Trial)

JL
Overseen ByJane Ledesma
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kansas Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12356

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.12356

Research Team

BB

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
See 4 more

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
2Treatment groups
Active Control
Group I: URS WITH INTRARENAL PRESSURE MONITORING VISIBLEActive Control1 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 VISIBLEActive Control1 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.

Find a Clinic Near You

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.
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.
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

Retrospective first-in-human use of the LithoVue™ Elite ureteroscope to measure intrarenal pressure. [2023]
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]
A Single-Center Prospective Comparative Study of Two Single-Use Flexible Ureteroscopes: LithoVue (Boston Scientific, USA) and Uscope PU3022a (Zhuhai Pusen, China). [2021]
Intrarenal pressures during percutaneous nephrolithotomy: a porcine kidney model. [2022]
Comparison of New Single-Use Digital Flexible Ureteroscope Versus Nondisposable Fiber Optic and Digital Ureteroscope in a Cadaveric Model. [2022]
First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security