Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2022
CompletedFirst Submitted
Initial submission to the registry
November 18, 2022
CompletedFirst Posted
Study publicly available on registry
December 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJune 27, 2024
June 1, 2024
6 months
November 18, 2022
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Scope performance
Difference in scope performance grading by multiple blinded reviewers
0-1 day
Secondary Outcomes (13)
Operating room outcomes
0-1 day
Operating room outcomes
0-1 day
Operating room outcomes
0-1 day
Operating room outcomes
0-1 day
Operating room outcomes
0-1 day
- +8 more secondary outcomes
Study Arms (3)
Storz Flex-XC1 disposable flexible ureteroscope
EXPERIMENTALA patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Analogue scope
NO INTERVENTIONA patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope.
Digital ureteroscope
EXPERIMENTALA patient is randomized to the experimental arm using a Digital ureteroscope.
Interventions
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
Related Publications (1)
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.
PMID: 39937281DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology
Study Record Dates
First Submitted
November 18, 2022
First Posted
December 12, 2022
Study Start
November 15, 2022
Primary Completion
May 5, 2023
Study Completion
December 31, 2023
Last Updated
June 27, 2024
Record last verified: 2024-06