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

NCT ID: NCT05646069

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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UTI Stone, Kidney

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Assignment
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Storz Flex-XC1 disposable flexible ureteroscope

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

Group Type EXPERIMENTAL

Storz Flex-XC1 Disposable Flexible Ureteroscope

Intervention Type DEVICE

Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.

Analogue scope

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Digital ureteroscope

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

Group Type EXPERIMENTAL

Storz Flexible Digital Ureteroscope

Intervention Type DEVICE

Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.

Interventions

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Storz Flex-XC1 Disposable Flexible Ureteroscope

Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.

Intervention Type DEVICE

Storz Flexible Digital Ureteroscope

Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Amy Krambeck

Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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Wong C, Xu P, Dean N, Assmus M, McDonald A, Agarwal D, Ali S, Abedi G, Margolin E, Medairos R, Nottingham C, Krambeck A. A prospective survey evaluating the visual quality of KARL STORZ fiberoptic, digital, and disposable flexible ureteroscopes. World J Urol. 2025 Feb 12;43(1):119. doi: 10.1007/s00345-025-05502-x.

Reference Type DERIVED
PMID: 39937281 (View on PubMed)

Other Identifiers

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STU00217933

Identifier Type: -

Identifier Source: org_study_id

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