Clinical trial · Observational
Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures
Evaluation of the Performance of a Disposable Cystoscope System for Direct Visualization of the Urethra and Bladder
NCT03331705CI-TRIAL-00030226unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.
Conditions
Conditions (1)
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 Tumor | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Uro-C (Use of new cystoscope) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Use of new cystoscope
- description
- Patients in which the cystoscope is used.
- interventionNames
- Device: Uro-C (Use of new cystoscope)
Primary outcomes (1)
- measure
- Assessment of the utility and performance of the cystoscope by the physician
- timeFrame
- during the procedure
- description
- Ranking with Likert Scale on ease of advancement, visibility of tissue and structures, and removal of the device
Secondary outcomes (1)
- measure
- Patient tolerance of the procedure
- timeFrame
- during and within 5 days after the procedure
- description
- Assess level of discomfort or adverse event associated with the procedure by the subject using the Likert Scale
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and 2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position. Exclusion Criteria: 1. History of prior bladder/urethral surgery other than TURBT; or 2. History of interstitial cystitis; or 3. Presence of urinary tract infection (UTI); or 4. Gross hematuria; or 5. History of pelvic radiation therapy; or 6. Procidentia; or 7. Unable to read, understand, and/or provide a ranking of pain level during the procedure; or 8. Unable or unwilling to provide consent to participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.