Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06576661

Evaluation of the LithoVue Elite Ureteroscope with Real-Time Intra-Renal Pressure Monitoring: Impact on Surgeon Behavior and Post-Operative Outcomes

Led by University of Kansas Medical Center · Updated on 2026-05-04

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how having real-time intrarenal pressure (IRP) measurement available during ureteroscopy affects surgeons' behavior when using the LithoVue Elite disposable ureteroscope. The study aims to understand whether this new technology impacts surgical decisions and patient outcomes during treatment for kidney stones or nephrolithiasis. This research also addresses the importance of surgeons' non-technical skills in preventing adverse events in the operating room. Participants will be randomly assigned to one of two groups. In the first group, surgeons will perform ureteroscopy with the LithoVue Elite device while seeing real-time IRP monitoring information. In the second group, surgeons will use the same device but without access to the IRP monitoring data. All procedures and follow-up visits will follow standard care practices for both groups. During the study, researchers will observe surgeon behavior using the Non-Technical Skills for Surgeons (NOTSS) score and look at decision-making differences. They will also monitor patient outcomes such as post-operative infections, pain levels using a visual analog scale, opioid use, and complications up to 30 days after surgery. This approach helps assess both surgical performance and patient safety over the short term.

CONDITIONS

Brief Title

Evaluation of the LithoVue Elite Ureteroscope With Intra-Renal Pressure Monitoring Technology: Examination of Surgeon Behavior and Post-operative Outcomes

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females over 18 years of age
  • Undergoing flexible ureteroscopy to treat urinary stones located in the proximal ureter or kidney
  • Total stone burden over 2 cm
Not Eligible

You will not qualify if you...

  • Undergoing bilateral stone treatment during the same procedure
  • Known genitourinary anatomical abnormalities
  • Uncorrected coagulopathy
  • Patients with urinary diversions
  • Chronic external urinary catheters
  • Women who are pregnant
  • Immunosuppressed patients

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Single day procedure

Participants undergo flexible ureteroscopy (URS) to treat urinary stones, with or without real-time intra-renal pressure monitoring visible to the surgeon using the LithoVue Elite™ device.

1 surgery visit (in-person)

Post-operative Follow-up

Duration - Up to 30 days

Participants are monitored for up to 30 days after surgery to assess post-operative infection, pain, opioid use, and other patient outcomes as per standard care.

Follow-up visits per standard of care

Trial Site Locations

Total: 1 location

1

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

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Research Team

J

Jane Ledesma

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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