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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 7 days
Awards & highlights

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 weeks
Treatment ~ Varies
Follow Up ~7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Scores on NOTSS tool
Secondary study objectives
Infection rates
Post operative pain

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.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
488 Previous Clinical Trials
172,375 Total Patients Enrolled
3 Trials studying Kidney Stones
250 Patients Enrolled for Kidney Stones
Bristol B Whiles, MDPrincipal InvestigatorUniversity of Kansas Medical Center
~53 spots leftby May 2025
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