abnormalities in urethra and bladder
Conditions
Interventions
The subjects will undergo a cystoscopy procedure.
Sponsors
Ambu AS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: i. Adults (males and females), *18 years of age or older, presenting for cystoscopy ii. Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes iii. Willing to participate in a clinical trial
Exclusion criteria
Exclusion criteria: i. History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes ii. History of prior bladder/urethral reconstructive surgery iii. Presence of symptomatic urinary tract infection (UTI) iv. Known unpassable urethral stricture v. Unable to read and/or understand the study requirements vi. Unable or unwilling to provide consent to participation in the study vii. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to evaluate the performance and safety of Ambu® aScope* 4 Cysto and aView* Urologia for flexible cystoscopy. Primary endpoint: - Rate of completion of procedure with Ambu® aScope* 4 Cysto and aView* Urologia (Yes/No, Yes applies to 80% of procedures) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Rate of overall performance during the procedure - Rate of pain level experienced by the subject when inserting the flexible cystoscope (measured on a visual analog scale - Overall procedure time from insertion of flexible cystoscope to removal The intended performances that will be investigated during this clinical investigation are: * Manoeuvrability o Insertion of the endoscope in the lower urinary tract o Navigation in the bladder o Use of endoscopic accessories in the working channel * Use of the working channel (eg. Irrigation and tools) * Visual examination of the urothelium * Visual confirmation of anatomical structures * Visual confirmation of abnormalities in urethra and bladder | — |
Countries
Netherlands
Outcome results
None listed