AI-Powered Research

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this study is to evaluate the performance and safety of Ambu®<br /><br>aScope* 4 Cysto and aView* Urologia for flexible cystoscopy.<br /><br>Primary endpoint: - Rate of completion of procedure with Ambu® aScope* 4 Cysto<br /><br>and aView* Urologia (Yes/No, Yes applies to 80% of procedures) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Rate of overall performance during the procedure<br /><br>- Rate of pain level experienced by the subject when inserting the flexible<br /><br>cystoscope (measured on a visual analog scale<br /><br>- Overall procedure time from insertion of flexible cystoscope to removal<br /><br><br /><br>The intended performances that will be investigated during this clinical<br /><br>investigation are:<br /><br>* Manoeuvrability<br /><br>o Insertion of the endoscope in the lower urinary tract<br /><br>o Navigation in the bladder<br /><br>o Use of endoscopic accessories in the working channel<br /><br>* Use of the working channel (eg. Irrigation and tools)<br /><br>* Visual examination of the urothelium<br /><br>* Visual confirmation of anatomical structures<br /><br>* Visual confirmation of abnormalities in urethra and bladder</p><br>