This study is designed to provide an evaluation of currently available disposable
flexible ureteroscopes in real-world conditions. Due to high re-processing costs
associated with re-usable flexible ureteroscopes, there has been a demand for Urologic
device manufacturers to provide single-use flexible ureteroscopes.

Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi

Stone, Kidney

Patients randomized to the experimental group will receive flexible ureteroscopy with the
Storz Flex-XC1 disposable flexible ureteroscope.

Data will be collected and stored electronically in REDCap. Quality assurance steps will
include testing of the database, including any potential data calculated by command
functions within REDCap

Scope performance survey will be administered with REDcap.

Storz Flex-XC1 Disposable Flexible Ureteroscope

Storz Flexible Digital Ureteroscope

Difference in scope performance grading by multiple blinded reviewers

Professor of Urology

The difference in operating room outcomes: basketing time

The difference in operating room outcomes: scope setup time

The difference in operating room outcomes: laser-use time

The difference in operating room outcomes: operative time

The difference in operating room outcomes: number of flexible ureteroscopes used

The difference in postoperative outcomes using a questionnaire: the patient has a UTI

The difference in postoperative outcomes using a questionnaire: the patient is stone-free

Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction
of the flexible ureteroscope (graded on a scale of 1-5)

A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable
flexible ureteroscope.

A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable
flexible ureteroscope.

A patient is randomized to the experimental arm using a Digital ureteroscope.

Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status