Last reviewed · How we verify
NCT04192474
Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy
NA trial testing Flexible cystoscopy in Cystoscope in 83 participants. Completed in 30 June 2021.
7 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 | other |
| Enrollment | 83 |
| Start date | 21 July 2020 |
| Primary completion | 7 April 2021 |
| Estimated completion | 30 June 2021 |
| Sites | 2 locations across Denmark, Netherlands |
Drugs / interventions tested
- Flexible cystoscopy
Conditions studied
- Cystoscope — all drugs for Cystoscope →
- Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
- Bladder Disease — all drugs for Bladder Disease →
Sponsor
Ambu A/S — full company profile →
Who can join
18 and older, any sex, with Cystoscope or Lower Urinary Tract Symptoms. 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 if this new single use, flexible cystoscope performs as well as other routinely used flexible cystoscopes. This study will be done in patients who come to the clinic for either a diagnosis of their urethra and bladder or for a small intervention. For an intervention a lesion or tumor is resected, a stent in the ureter is taken out, or an injection in the bladder wall is given. The flexible cystoscope is passed into the urethra and bladder for visual inspection of the bladder and urethra. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present. If an intervention is performed the aScope 4 Cysto will be used with an endoscopic accessory.
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 NCT04192474
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Flexible cystoscopy
Trials testing the same drug.
- NCT05643807 — Bladder Washing Cytology for Detection of Urothelial Carcinoma Using Catheter or Flexible Cystoscope: Which is Better? · NA · unknown
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
- NCT04190641 — Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder · 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 NCT04192474 (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/NCT04192474.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing