NCT05646069

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• UTI
• Stone, Kidney

Interventions

Type	Name	Description
DEVICE	Storz Flex-XC1 Disposable Flexible Ureteroscope	Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
DEVICE	Storz Flexible Digital Ureteroscope	Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-05-05
• Completion: 2023-12-31
• First posted: 2022-12-12
• Last updated: 2024-06-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study