Clinical trial · Interventional
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
Clinical Investigation to Evaluate the Direct Visualization Performances of Ambu® aScope™ 4 Cysto and aView™ Urologia for Examination of the Lower Urinary Tract
- 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)
In this study, the new aScope 4 Cysto is used to see how well it visualizes the lower urinary tract, and if this new flexible cystoscope performs as well as other routinely used cystoscopes. This study will be done in patients who have been diagnosed with bladder lesions and who will undergo surgery via the urethra to remove these lesions. The surgery is done under general anesthesia. After being brought under anesthesia and before removal of the lesion(s), the new flexible cystoscope is tested. The cystoscope will be used to visualize the urethra and bladder. Data will be collected on the number of the lesions that can be seen using the new cystoscope. During the planned surgery a resectoscope or rigid cystoscope will be used to confirm the number of lesions. The data will be used to show how well the cystoscope visualizes the lesions in comparison with routinely used cystoscopes. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present.Data will also be collected on the handling of the cystoscope: how well the cystoscope moves into the lower urinary tract, and how well it can be navigated through the lower urinary tract.
Conditions
Conditions (3)
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 |
| Cystoscope | — | UNRESOLVED | — |
| Lower Urinary Tract Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ambu aScope 4 Cysto and aView Urologia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Flexible cystoscopy
- description
- Visualization of the urethra and bladder with the Ambu® aScope™ 4 Cysto and aView™ Urologia
- interventionNames
- Device: Ambu aScope 4 Cysto and aView Urologia
Primary outcomes (1)
- measure
- performance of Ambu® aScope™ 4 Cysto and aView™ Urologia
- timeFrame
- follow up immediately after procedure
- description
- The performance level of Ambu® aScope™ 4 Cysto and aView™ Urologia, compared to current standard practice with re-usable cystoscopes, is defined as proportion of patients with one or more papillary bladder lesion or small resectable lesion (diagnosed a maximum of one month prior to resection) detected with the Ambu® aScope™ 4 Cysto and aView™ Urologia (prior to planned transurethral resection of bladder tumors (TURBT)) and confirmed with the rigid cystoscope during TURBT.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Willing to sign the informed consent * Adults (males and females), ≥18 years of age or older * Able to undergo routine cystoscopy * Patients diagnosed with papillary bladder or small resectable lesion where transurethral resection of the tumour/lesion is planned Exclusion Criteria: * History of prior bladder/urethral reconstructive surgery * Presence of symptomatic urinary tract infection (UTI) * Known unpassable urethral stricture * Unable to read and/or understand the study requirements * Pregnant or lactating women
References
Publications (0)
Data not yet available