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

Northwestern University

Status: Completed

Conditions: Stone, Kidney; UTI

Treatments: Device: Storz Flex-XC1 Disposable Flexible Ureteroscope; Device: Storz Flexible Digital Ureteroscope

Study type: Interventional

Funder types: Other

Identifiers

NCT05646069

STU00217933

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Storz Flex-XC1 disposable flexible ureteroscope

Experimental group

Description:

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

Treatment:

Device: Storz Flex-XC1 Disposable Flexible Ureteroscope

Analogue scope

No Intervention group

Description:

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

Digital ureteroscope

Experimental group

Description:

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

Treatment:

Device: Storz Flexible Digital Ureteroscope