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

Not Applicable

Completed

• Conditions: Stone, Kidney; UTI
• Interventions: Device: Storz Flex-XC1 Disposable Flexible Ureteroscope; Device: Storz Flexible Digital Ureteroscope

• Registration Number: NCT05646069
• Lead Sponsor: Northwestern University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-15
• Study First Submitted: 2022-11-18
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-12
• Primary Completion: 2023-05-05
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Storz Flex-XC1 disposable flexible ureteroscope	Storz Flex-XC1 Disposable Flexible Ureteroscope	A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Digital ureteroscope	Storz Flexible Digital Ureteroscope	A patient is randomized to the experimental arm using a Digital ureteroscope.

Primary Outcome Measures

Name	Time	Method
Scope performance	0-1 day	Difference in scope performance grading by multiple blinded reviewers

Secondary Outcome Measures

Name	Time	Method
Operating room outcomes	0-1 day	The difference in operating room outcomes: number of flexible ureteroscopes used
Post-operative outcomes	4-6 weeks	The difference in postoperative outcomes using a questionnaire: the patient is stone-free
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference	4-6 weeks	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)
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)	4-6 weeks	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)
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)	4-6 weeks	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)
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference	4-6 weeks	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)
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view	4-6 weeks	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)
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression	4-6 weeks	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)

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States