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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05646069
Other study ID # STU00217933
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date December 31, 2023

Study information

Verified date January 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date December 31, 2023
Est. primary completion date May 5, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: - Males and Females 18-89 undergoing ureteroscopy for laser treatment of renal calculi - Willing to sign the Informed Consent Form - Able to read, understand, and complete patient questionnaires, pain texts, and medication diary. Exclusion Criteria: - Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL) - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Storz Flex-XC1 Disposable Flexible Ureteroscope
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Storz Flexible Digital Ureteroscope
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Scope performance Difference in scope performance grading by multiple blinded reviewers 0-1 day
Secondary Operating room outcomes The difference in operating room outcomes: basketing time 0-1 day
Secondary Operating room outcomes The difference in operating room outcomes: scope setup time 0-1 day
Secondary Operating room outcomes The difference in operating room outcomes: laser-use time 0-1 day
Secondary Operating room outcomes The difference in operating room outcomes: operative time 0-1 day
Secondary Operating room outcomes The difference in operating room outcomes: number of flexible ureteroscopes used 0-1 day
Secondary Post-operative outcomes The difference in postoperative outcomes using a questionnaire: the patient has a UTI 4-6 weeks
Secondary Post-operative outcomes The difference in postoperative outcomes using a questionnaire: the patient is stone-free 4-6 weeks
Secondary Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution) 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) 4-6 weeks
Secondary Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color) 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) 4-6 weeks
Secondary Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference 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) 4-6 weeks
Secondary Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference 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) 4-6 weeks
Secondary Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view 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) 4-6 weeks
Secondary Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression 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) 4-6 weeks
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