UTINCT05646069
Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
A study testing Storz Flex-XC1 Disposable Flexible Ureteroscope and Storz Flexible Digital Ureteroscope in people with UTI and Stone, Kidney, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- UTI, Stone, Kidney
- What is being tested?
- Storz Flex-XC1 Disposable Flexible Ureteroscope and Storz Flexible Digital Ureteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Storz Flex-XC1 Disposable Flexible Ureteroscope, Storz Flexible Digital Ureteroscope
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Storz Flex-XC1 Disposable Flexible UreteroscopeDevice
Patients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope.
Storz Flexible Digital UreteroscopeDevice
Patients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope.
| Study group | Role | What they receive |
|---|---|---|
| Storz Flex-XC1 disposable flexible ureteroscope | Experimental | A patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. Receives: Device: Storz Flex-XC1 Disposable Flexible Ureteroscope |
| Analogue scope | No intervention | A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. |
| Digital ureteroscope | Experimental | A patient is randomized to the experimental arm using a Digital ureteroscope. Receives: Device: Storz Flexible Digital Ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scope performance
Difference in scope performance grading by multiple blinded reviewers
Measured: 0-1 day
Secondary outcomes (13)
Operating room outcomes
The difference in operating room outcomes: basketing time
Measured: 0-1 day
Operating room outcomes
The difference in operating room outcomes: scope setup time
Measured: 0-1 day
Operating room outcomes
The difference in operating room outcomes: laser-use time
Measured: 0-1 day
Operating room outcomes
The difference in operating room outcomes: operative time
Measured: 0-1 day
Operating room outcomes
The difference in operating room outcomes: number of flexible ureteroscopes used
Measured: 0-1 day
Post-operative outcomes
The difference in postoperative outcomes using a questionnaire: the patient has a UTI
Measured: 4-6 weeks
Post-operative outcomes
The difference in postoperative outcomes using a questionnaire: the patient is stone-free
Measured: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Measured: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Measured: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Measured: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Measured: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Measured: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression
Post-operative, the surgeon will watch videos of each surgery to analyze the satisfaction of the flexible ureteroscope (graded on a scale of 1-5)
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start15 Nov 2022
- Primary completion5 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UTIStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646069
- Sponsor's protocol ID
- STU00217933
- Status last verified
- Jun 2024
- First submitted
- 18 Nov 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 39937281
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Novel Disposable Flexible Ureteroscope for the Treatment of Renal Calculi
- ClinicalTrials.gov ID
- NCT05646069
- Acronym / sponsor ID
- STU00217933
- Conditions
- UTI, Stone, Kidney
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Storz Flex-XC1 disposable flexible ureteroscope | Experimental | Device: Storz Flex-XC1 Disposable Flexible UreteroscopeA patient is randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. |
| Analogue scope | No intervention | –A patient is not randomized to the experimental arm using the Storz Flex-XC1 disposable flexible ureteroscope. |
| Digital ureteroscope | Experimental | Device: Storz Flexible Digital UreteroscopeA patient is randomized to the experimental arm using a Digital ureteroscope. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients having a concomitant procedure along with ureteroscopy (example: contralateral PCNL)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Storz Flex-XC1 Disposable Flexible UreteroscopePatients will receive flexible ureteroscopy with the Storz Flex-XC1 disposable flexible ureteroscope. | Device | Storz Flex-XC1 disposable flexible ureteroscope |
| Storz Flexible Digital UreteroscopePatients will receive flexible ureteroscopy with the Storz flexible Digital ureteroscope. | Device | Digital ureteroscope |
Primary outcome
Scope performance
Time frame: 0-1 day
Difference in scope performance grading by multiple blinded reviewers
13 secondary outcomes
Operating room outcomes
Time frame: 0-1 day
Operating room outcomes
Time frame: 0-1 day
Operating room outcomes
Time frame: 0-1 day
Operating room outcomes
Time frame: 0-1 day
Operating room outcomes
Time frame: 0-1 day
Post-operative outcomes
Time frame: 4-6 weeks
Post-operative outcomes
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (resolution)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: visual quality (color)
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: color interference
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: laser interference
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: field of view
Time frame: 4-6 weeks
Post-operative surgery satisfaction of the flexible utereoscope using a questionnaire: overall impression
Time frame: 4-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 39937281Wong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Storz Flex-XC1 Disposable Flexible Ureteroscope and Storz Flexible Digital Ureteroscope in people with UTI and Stone, Kidney, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scope performance (time frame: 0-1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.