Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder

Summary

Participation Requirements

Description

Clinical Phase: pre-CE study Design: A non-randomized confirmatory study on the visualization performance of the Ambu® aScope™ 4 Cysto and aView™ Urologia in 42 fully evaluable, adults subjects aimed at identification of known pathological findings (papillary bladder or small resectable lesion) dete...

Clinical Phase: pre-CE study Design: A non-randomized confirmatory study on the visualization performance of the Ambu® aScope™ 4 Cysto and aView™ Urologia in 42 fully evaluable, adults subjects aimed at identification of known pathological findings (papillary bladder or small resectable lesion) detected with Ambu® aScope™ 4 Cysto and aView™ Urologia and subsequently during a repeat procedure using a reusable rigid scope or resectoscope at the time of planned transurethral resection of bladder tumours (TURBT). Population: Adult subjects (? 18 years) in the OR undergoing planned transurethral resection of bladder tumors TURBT Planned sample size: A total of 42 patients will result in a maximum (if the true proportion is 50 %) width of the two-sided 95 % confidence interval for the binary variable "Confirmed" to be 15%. This width is considered to be useful in the interpretations of the results from this investigation. Study duration: Screening, procedure and follow-up will take 15 days maximum Follow-up duration: Follow-up immediately after procedure Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia Pre-CE, single use cystoscope.

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