Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
NCT ID: NCT05646069
Last Updated: 2024-06-27
Study Results
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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COMPLETED
NA
6 participants
INTERVENTIONAL
2022-11-15
2023-12-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
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.
Storz Flex-XC1 Disposable Flexible Ureteroscope
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.
No interventions assigned to this group
Digital ureteroscope
A patient is randomized to the experimental arm using a Digital ureteroscope.
Storz Flexible Digital Ureteroscope
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.
Storz Flexible Digital Ureteroscope
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
Eligibility Criteria
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Inclusion Criteria
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
Exclusion Criteria
* Pregnancy
18 Years
89 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Amy Krambeck
Professor of Urology
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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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.
Other Identifiers
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STU00217933
Identifier Type: -
Identifier Source: org_study_id
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