LithoVue Elite Ureteroscope for Kidney Stones

(LVE Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen by Naeem Bhojani, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Pregnancy, Nephrostomy tube, Hydronephrosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Flexible ureteroscopy has become the main surgical treatment for kidney stone disease. The procedure uses many types of ureteroscopes (disposable and non-disposable). Currently we are using the LithoVue Single-Use Digital Flexible Ureteroscope. The Health Canada approved LithoVue Elite disposable flexible ureteroscope will now offer novel pressure sensory capacity. In order to evaluate the new ureteroscopy we will be conducting a prospective multi-institution study in order to determine the main features, capacity and abilities of the new scope. We will evaluate the impact of intra renal pressure on pain, quality of life and possible infectious complications.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the LithoVue Elite Ureteroscope treatment for kidney stones?

Research shows that the LithoVue single-use digital flexible ureteroscope is effective in treating kidney stones, offering good image quality and maneuverability. It also eliminates the need for costly repairs and reduces procedural delays, making it a practical choice for high-volume centers.

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Is the LithoVue Elite Ureteroscope generally safe for use in humans?

The LithoVue Elite Ureteroscope, a single-use device, has been used in procedures for kidney stones and compared to reusable ureteroscopes. While specific safety data is limited, its use in humans has been documented without reports of significant safety concerns.

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How is the LithoVue Elite treatment for kidney stones different from other treatments?

The LithoVue Elite is a single-use digital flexible ureteroscope, which means it is used once and then disposed of, eliminating the need for costly repairs and reprocessing associated with reusable scopes. It offers improved flexibility and image quality, making it particularly effective for accessing challenging areas in the kidney, such as the lower pole, during stone removal procedures.

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Eligibility Criteria

This trial is for adults over 18 with kidney stones that are not causing a blockage and measure 2 cm or less in total diameter. It's not for those under 18, pregnant individuals, people with unusual kidney shapes, severe swelling of the kidneys, or those who have a tube inserted to drain their kidney.

Inclusion Criteria

I am older than 18 years.

I am scheduled for a procedure to remove kidney stones using lasers.

I have a kidney stone smaller than 2 cm and am getting a flexible ureteroscopy.

Exclusion Criteria

I have kidney abnormalities.

I am under 18 years old.

You are pregnant.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Preoperative assessments including imaging, questionnaires, and baseline measurements

1 day

1 visit (in-person)

Treatment

Ureteroscopy with LithoVue Elite ureteroscope and laser lithotripsy

1 day

1 visit (in-person)

Postoperative (1-2 weeks)

Stent removal and follow-up assessments

1-2 weeks

1 visit (in-person or virtual)

Follow-up

Standard of care imaging and assessment of stone-free rate and quality of life

4-8 weeks

1 visit (in-person)

Participant Groups

The study is testing the LithoVue Elite ureteroscope—a new disposable scope with pressure sensing abilities—during surgery to remove kidney stones using lasers. The goal is to see how it affects pain levels, quality of life, and risk of infection.

Group I: Ureteroscopy (URS) with the LithoVue Elite disposable flexible ureteroscope Experimental Treatment 1 Intervention

Ureteroscopy will be done using the LithoVue Elite disposable flexible ureteroscope instead of the satandard ureteroscope

LithoVue 2.0 is already approved in United States, Canada for the following indications:

🇺🇸 Approved in United States as LithoVue Elite for:

• Visualization of organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae)
• Diagnostic and therapeutic procedures in the urinary tract

🇨🇦 Approved in Canada as LithoVue Elite for:

• Visualization of organs, cavities, and canals in the urinary tract (urethra, bladder, ureter, calyces, and renal papillae)
• Diagnostic and therapeutic procedures in the urinary tract

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Hôpital Maisonneuve-Rosemont (HMR) Montréal-Est, Canada

CHU de Québec-Université Laval Québec, Canada

Centre Hospitalier de l'Université de Montréal (CHUM) Montréal, Canada

Western University London, Canada

More Trial Locations

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM) Lead Sponsor

Western University, Canada Collaborator

University of British Columbia Collaborator

Laval University Collaborator

Université de Montréal Collaborator

University of Saskatchewan Collaborator

References

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

LithoVue™ for renal stone therapy - a perfect fit for high volume academic centers; a retrospective evaluation of 108 cases. [2021] Over the last few years the number of flexible ureterorenoscopies, used for renal stone treatment, has risen steadily. This was associated with an increase in costs for maintenance and repair of the fragile ureterorenoscopes used. To overcome this problem single-use devices have been introduced to the market. The aim of this study was to assess surgical outcome and workability for LithoVue™, a single-use flexible ureterorenoscope.

2. England pubmed.ncbi.nlm.nih.gov

Single-use disposable digital flexible ureteroscopes: an ex vivo assessment and cost analysis. [2019] To assess and measure the capability of a single-use disposable digital flexible ureteroscope, the LithoVue™ (Boston Scientific, Marlborough, MA, USA), and to assess if there is a benefit to switching to single-use scopes.

3. Germany pubmed.ncbi.nlm.nih.gov

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study. [2022] We evaluated a new digital single-use flexible ureteroscope, LithoVue™ with respect to deflection, image quality and maneuverability.

4. 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] To evaluate LithoVue, the new single-use digital flexible ureteroscope, in a human cadaveric model and compare it with a nondisposable fiber optic and digital flexible ureteroscopes.

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

Impressive Performance: New Disposable Digital Ureteroscope Allows for Extreme Lower Pole Access and Use of 365 μm Holmium Laser Fiber. [2020] Since the development of the first flexible ureteroscope, in 1964, technological advances in image quality, flexibility, and deflection have led to the development of the first single-use digital flexible ureteroscope, LithoVue™ (Boston Scientific, Marlborough, MA). With respect to reusable fiber-optic and now digital ureteroscopes, there is an initial capital cost of several thousand dollars (USD) as well as, controversy regarding durability, the cost of repairs and the burdensome reprocessing steps of ureteroscopy. The single-use LithoVue eliminates the need for costly repairs, the occurrence of unpredictable performance, and procedural delays. Renal stones located in the lower pole of the kidney can be extremely challenging as extreme deflections of greater than 160° are difficult to maintain and are often further compromised when using stone treatment tools, such as laser fibers and baskets. This case describes an initial use of the LithoVue digital disposable ureteroscope in the effective treatment of lower pole calculi using a 365 μm holmium laser fiber.

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

A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. [2022] LithoVue™ is a novel, single-use, digital flexible ureteroscope that was released to the US market in January 2016. There are scant data regarding its performance in humans. Procedural outcomes comparing LithoVue with reusable ureteroscopes are presented in patients undergoing ureteroscopy for upper urinary tract pathology.