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Procedure

LithoVue Elite Ureteroscope for Kidney Stones (ELITE Trial)

N/A

Waitlist Available

Led By Bristol B Whiles, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergoing flexible ureteroscopy to address urinary stones located in the proximal ureter or kidney

Total stone burden over 2 cm

Must not have

Undergoing bilateral stone treatment during the same procedure

Patients with known genitourinary anatomical abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see how surgeons' behavior changes during ureteroscopy when they have real-time intrarenal pressure measurements using the LithoVue Elite ureteroscope."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since specific side effects are not listed for the intervention being tested (real-time pressure monitoring), they may include typical risks associated with ureteroscopy such as discomfort, infection risk, or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My kidney stones are larger than 2 cm in total.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a known abnormality in my urinary system.

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I am currently pregnant.

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I have a bleeding disorder that hasn't been treated.

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I have a urinary diversion.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Surgeon behavior as measured by mean Non-Technical Skills for Surgeons (NOTSS) score.

Secondary study objectives

Difference in decision-making domain scores as measured by the Non-Technical Skills for Surgeons (NOTSS) scores

Perioperative patient outcomes as measured by Clavien-Dindo classification system

Post-operative infection

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met