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

Stone, Kidney Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05646069
• Other study ID #: STU00217933
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Stone, Kidney
• UTI

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