Clinical trial · Interventional
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.
NCT06422312CI-TRIAL-00088129withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): A change in marketing strategy resulted in a decision to not complete the trial.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Bladder Outlet Obstruction | — | UNRESOLVED | — |
| Bladder Stone | — | UNRESOLVED | — |
| Renal Disease | — | UNRESOLVED | — |
| Renal Stone | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cystoscopy with RedPine flexible disposable cystoscope | Device | — | UNRESOLVED |
| Cystoscopy with standard of care flexible reusable scope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.
- interventionNames
- Device: Cystoscopy with standard of care flexible reusable scope
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.
- interventionNames
- Device: Cystoscopy with RedPine flexible disposable cystoscope
Primary outcomes (1)
- measure
- Cumulative Procedure Time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female, aged at least 18 years old 2. Patient undergoing routine flexible cystoscopy 3. No active urinary tract infection 4. Subject is willing and able to sign informed consent and HIPAA authorization. Exclusion Criteria: 1. Known unpassable urethral stricture 2. Febrile patient with active urinary tract infection (UTI) 3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 4. Subject with severe coagulopathy 5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
References
Publications (7)
- BACKGROUNDSamplaski 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. PMID 19076146
- BACKGROUNDO'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. PMID 8081563
- BACKGROUNDPoulton LJ, Joyce AD. Flexible cystoscopy: Training and Assessment Guideline. Br Assoc Urol Nurses. 2012;(November).
- BACKGROUNDPillai 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. PMID 19966704
- BACKGROUNDKadi 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. PMID 21887113
- BACKGROUNDSteinberg. Cystoscopy in Bladder Carcinoma [Internet]. Medscape. 2015 [cited 2018 Jan 18]. Available from: https://emedicine.medscape.com/article/1950345-overview
- BACKGROUNDDoizi 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. PMID 27988848