Last reviewed · How we verify
NCT04190641
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder
NA trial testing Ambu aScope 4 Cysto and aView Urologia in Cystoscope in 4 participants. Completed in 6 July 2021.
30 April 2021
Quick facts
| Lead sponsor | Ambu A/S |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 4 |
| Start date | 8 October 2020 |
| Primary completion | 30 April 2021 |
| Estimated completion | 6 July 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Ambu aScope 4 Cysto and aView Urologia
Conditions studied
- Cystoscope — all drugs for Cystoscope →
- Bladder Cancer — all drugs for Bladder Cancer →
- Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
Sponsor
Ambu A/S — full company profile →
Who can join
18 and older, any sex, with Cystoscope or Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04190641
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Ambu A/S trials
Trials by the same sponsor.
- NCT06465797 — Observational Bronchoscopy Video Data Collection Study With Adult Patients · completed
- NCT05198219 — Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults · NA · unknown
- NCT04628949 — A Single-Use Duodenoscope in a Real-World Setting · NA · completed
- NCT04192474 — Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy · NA · completed
- NCT04128527 — AuraOnce Performance Observation · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04190641 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ambu A/S
- Last refreshed: 14 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04190641.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing