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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Investigation to Evaluate the Direct Visualization Performances of Ambu® aScope™ 4 Cysto and aView™ Urologia for Examination of the Lower Urinary Tract

Conditions
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Cystoscope, Bladder Cancer, Lower Urinary Tract Symptoms

Intervention / Treatment
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* Device: Ambu aScope 4 Cysto and aView Urologia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to sign the informed consent Adults (males and females), ≥18 years of age or older Able to undergo routine cystoscopy Patients diagnosed with papillary bladder or small resectable lesion where transurethral resection of the tumour/lesion is planned Exclusion Criteria: History of prior bladder/urethral reconstructive surgery Presence of symptomatic urinary tract infection (UTI) Known unpassable urethral stricture Unable to read and/or understand the study requirements Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A non-randomized confirmatory study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Flexible cystoscopy<br>Visualization of the urethra and bladder with the Ambu® aScope™ 4 Cysto and aView™ Urologia | Device: Ambu aScope 4 Cysto and aView Urologia<br>* Visualization of the urethra and the bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of Ambu® aScope™ 4 Cysto and aView™ Urologia | The performance level of Ambu® aScope™ 4 Cysto and aView™ Urologia, compared to current standard practice with re-usable cystoscopes, is defined as proportion of patients with one or more papillary bladder lesion or small resectable lesion (diagnosed a maximum of one month prior to resection) detected with the Ambu® aScope™ 4 Cysto and aView™ Urologia (prior to planned transurethral resection of bladder tumors (TURBT)) and confirmed with the rigid cystoscope during TURBT. | follow up immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia | Evaluate the safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for direct visualization of the urethra and bladder by assessing the adverse events during and immediately after the flexible cystoscopy with Ambu® aScope™ 4 Cysto and aView™ Urologia, prior to start of TURBT | follow up immediately after procedure | 
| Investigator performance | Measure of the overall performance by using a 5-point Likert scale with a minimum of one (=worst possible) to maximum of five (=best possible), to be completed by the investigator that performed the cystoscopy. | follow up immediately after procedure | 
| Procedure time | Measure of the overall procedure time | follow up immediately after procedure |