Bladder CancerNCT06422312
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
A study testing Cystoscopy with RedPine flexible disposable cystoscope in people with Bladder Cancer and Bladder Stone, run by Guangzhou Red Pine Medical Instrument Co., Ltd. at 3 sites in United States.
Trial summary
This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer, Bladder Stone, Bladder Outlet Obstruction
- What is being tested?
- Cystoscopy with RedPine flexible disposable cystoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2024to Jul 2025
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged at least 18 years old
- Patient undergoing routine flexible cystoscopy
- No active urinary tract infection
- Subject is willing and able to sign informed consent and HIPAA authorization.
Who cannot join
- Known unpassable urethral stricture
- Febrile patient with active urinary tract infection (UTI)
- Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
- Subject with severe coagulopathy
- Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UT Southwestern Medical Center
Dallas, Texas, 75390
Pennsylvania State University
Hersey, Pennsylvania, 17033
University of Washington
Seattle, Washington, 98195
About this study
Official title: Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.
Read the detailed description
This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.
- Being tested
- Cystoscopy with RedPine flexible disposable cystoscope, Cystoscopy with standard of care flexible reusable scope
- Keywords
- cystoscopy
- Medical subject headings
- Urinary Bladder Neoplasms, Urinary Bladder Calculi, Urinary Bladder Neck Obstruction, Nephrolithiasis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystoscopy with RedPine flexible disposable cystoscopeDevice
Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.
Cystoscopy with standard of care flexible reusable scopeDevice
Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice. Receives: Device: Cystoscopy with standard of care flexible reusable scope |
| Intervention | Experimental | Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope. Receives: Device: Cystoscopy with RedPine flexible disposable cystoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Procedure Time
To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by:
- Scope preparation for procedure
- Actual procedure time (insertion of cystoscope to complete bladder examination) and
- Time to dispose of or prepare for reprocessing of cystoscopy equipment.
Measured: 30 minutes
Secondary outcomes (4)
User experience and product performance during cystoscopic procedures
Physician satisfaction, rated on a five-point scale.
Scale Name Very Difficult Very Easy Outcome
Ease of insertion 1 5 5 = Better
Ability to visualize anatomical landmarks and/or urothelium changes 1 5 5 = Better
Perception of image quality 1 5 5 = Better
Maneuverability in the bladder 1 5 5 = Better
Overall Acceptability Yes/No
Measured: within 24 hours
Participant comfort during the procedure
Participants will be interviewed using a questionnaire. Pain Intensity Please respond to the question by marking one box.
How would you rate your pain on average? 0 1 2 3 4 5 6 7 8 9 10 No pain Worst imaginable pain
Measured: 30 minutes
RedPine Cystoscope Conversion Rate
Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.
Measured: 30 minutes
Device Failure Rate
Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study startOct 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJul 2025 (estimated)
Why it stopped: A change in marketing strategy resulted in a decision to not complete the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center, University of Washington, Penn State University
- Responsible party
- Principal investigator, Yair Lotan, MD, University of Texas Southwestern Medical Center
- Investigators
- Yair Lotan, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422312
- Sponsor's protocol ID
- USA001
- Status last verified
- Sep 2024
- First submitted
- 15 May 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.
PubMed 19076146O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
PubMed 8081563Poulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).
Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.
PubMed 19966704Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.
PubMed 21887113Steinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview
Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris): a European prospective multicenter study. World J Urol. 2017 Aug;35(8):1269-1275. doi: 10.1007/s00345-016-1986-0. Epub 2016 Dec 17.
PubMed 27988848
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
- ClinicalTrials.gov ID
- NCT06422312
- Acronym / sponsor ID
- USA001
- Keywords
- cystoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A change in marketing strategy resulted in a decision to not complete the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangzhou Red Pine Medical Instrument Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center, University of Washington, Penn State University
- Study start
- Oct 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 20 May 2024 (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 will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.
Detailed description
This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Cystoscopy with standard of care flexible reusable scopeParticipants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice. |
| Intervention | Experimental | Device: Cystoscopy with RedPine flexible disposable cystoscopeParticipants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, aged at least 18 years old
- Patient undergoing routine flexible cystoscopy
- No active urinary tract infection
- Subject is willing and able to sign informed consent and HIPAA authorization.
Key exclusion criteria (5 listed)
- Known unpassable urethral stricture
- Febrile patient with active urinary tract infection (UTI)
- Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
- Subject with severe coagulopathy
- Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
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 |
|---|---|---|
| Cystoscopy with RedPine flexible disposable cystoscopeUse of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents. | Device | Intervention |
| Cystoscopy with standard of care flexible reusable scopeUse of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents | Device | Control |
Primary outcome
Cumulative Procedure Time
Time frame: 30 minutes
To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by: * Scope preparation for procedure * Actual procedure time (insertion of cystoscope to complete bladder examination) and * Time to dispose of or prepare for reprocessing of cystoscopy equipment.
4 secondary outcomes
User experience and product performance during cystoscopic procedures
Time frame: within 24 hours
Participant comfort during the procedure
Time frame: 30 minutes
RedPine Cystoscope Conversion Rate
Time frame: 30 minutes
Device Failure Rate
Time frame: 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Background: PubMed 19076146Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.
- Background: PubMed 8081563O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
- BackgroundPoulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).
- Background: PubMed 19966704Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.
- Background: PubMed 21887113Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.
- BackgroundSteinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview
- Background: PubMed 27988848Doizi S, Kamphuis G, Giusti G, Palmero JL, Patterson JM, Proietti S, Straub M, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible cystoscope dedicated to double-J stent removal (Isiris): a European prospective multicenter study. World J Urol. 2017 Aug;35(8):1269-1275. doi: 10.1007/s00345-016-1986-0. Epub 2016 Dec 17.
- Individual participant dataSharing planned: No
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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.
Yair Lotan, MD principal investigator
University of Texas Southwestern Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystoscopy with RedPine flexible disposable cystoscope in people with Bladder Cancer and Bladder Stone, run by Guangzhou Red Pine Medical Instrument Co., Ltd. at 3 sites 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Cumulative Procedure Time (time frame: 30 minutes). 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 NCT06422312, which also lists 7 linked publications.
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 4 Apr 2025.