An interventional study of Cystoscopy with RedPine flexible disposable cystoscope and Cystoscopy with standard of care flexible reusable scope in Bladder Cancer, Bladder Stone and Bladder Outlet Obstruction, sponsored by Guangzhou Red Pine Medical Instrument Co., Ltd.. Withdrawn at 3 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by Guangzhou Red Pine Medical Instrument Co., Ltd. · Not applicable, Interventional, and Health services research
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.
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.
1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.
Browse Urinary Bladder Neoplasms studies →This is the only study on the registry with Guangzhou Red Pine Medical Instrument Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.
Device: Cystoscopy with standard of care flexible reusable scope
Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.
Device: Cystoscopy with RedPine flexible disposable cystoscope
Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.
Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents
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.
Time frame: 30 minutes
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
Time frame: 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
Time frame: 30 minutes
RedPine Cystoscope Conversion Rate
Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.
Time frame: 30 minutes
Device Failure Rate
Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.
Time frame: 30 minutes
Safety Endpoints
Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure. 1) All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure. The subject will be asked if they have had: 1. any signs or symptoms of a UTI 2. any untoward effects post-procedure, including by not limited to 1. gross hematuria last longer than 3 days post-procedure 2. pain with urination lasting longer than 3 days post-procedure 3. cloudy urine noted greater than one day post-procedure 4. fever/chills or a diagnosis of UTI or other illness within the time since the cystoscopic procedure. 2) All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure 3) All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure
Time frame: 4 to 10 days
Plan to share: No
Start is estimated for Oct 2024; primary completion for Jan 2025, 3 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.