LithoVue Elite Ureteroscope for Kidney Stones (LVE Trial)

N/A

Recruiting

Led By Naeem Dr Bhojani, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

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

Must have

Age > 18 years

Patient scheduled for ureteroscopy and laser lithotripsy

Must not have

Renal anomalies

Age < 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and in the recovery room after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new type of ureteroscope that has pressure-sensing ability. The goal is to see if this new scope can reduce pain and complications related to kidney stones.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for the device itself, typical risks from ureteroscopy procedures include discomfort during urination, minor bleeding in urine, possible infections and rarely injury to the ureters.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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

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

Exclusion Criteria

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

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I have kidney abnormalities.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, 1-2 weeks after surgery and 4-8 weeks after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, 1-2 weeks after surgery and 4-8 weeks after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1-2 weeks after surgery and 4-8 weeks after surgery for reporting.