Evaluation of Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
Clinical Phase: pre-CE study Design: A prospective, multicenter, single- arm open-label clinical study on the performance and safety of Ambu® aScope™ 4 Cysto and aView™ Urologia, a single-use, flexible cystoscope for flexible cystoscopy Population: Adult subjects (≥ 18 years) undergoing flexible cystoscopy for diagnostic or therapeutic purposes. Planned Sample Size: A total of 80 patients will result in a maximum (if the true proportion is 50 %) width (i.e. the difference between the point estimate and the upper, or lower, limit of the confidence interval) of the two-sided 95 % confidence interval for the binary variable Performance level acceptable to be 11%. This width is considered to be useful in the interpretations of the results from this part of the trial. Study duration: Screening, procedure and follow-up will take 14 days maximum. A follow-up telephone call at 7 days post procedure is performed to record any adverse events post-procedure. Planned Trial Period: 3 months Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia. A pre-CE, single use cystoscope.

Official Title
-----------------
Clinical Investigation to Evaluate the Performance and Safety of Ambu® aScope™ 4 Cysto and aView™ Urologia for Flexible Cystoscopy

Conditions
-----------------
Cystoscope, Lower Urinary Tract Symptoms, Bladder Disease

Intervention / Treatment
-----------------
* Device: Flexible cystoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (males and females), ≥18 years of age or older, presenting for cystoscopy Ambulatory with a need to undergo cystoscopy for diagnostic or therapeutic purposes Willing to participate in a clinical trial Exclusion Criteria: History of high-grade bladder cancer or carcinoma-in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes 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 Unable or unwilling to provide consent to participation in the study Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: A prospective, multicenter, single- arm open-label clinical study on the performance and safety 50% of the patients undergo flexible diagnostic cystoscopy 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Flexible cystoscopy<br>50% of the patients undergo flexible diagnostic cystoscopy; 50% of the patients undergo flexible cystoscopy intervention with endoscopic accessories. | Device: Flexible cystoscopy<br>* Treatment with the investigational device: Ambu® aScope™ 4 Cysto<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the cystoscope | Rate of completion of procedure with Ambu® aScope™ 4 Cysto and aView™ Urologia (yes/no, yes applies to 80% of the procedures) | follow up immediately after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall performance | The overall performance will be further assessed 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 | Procedure time in minutes | follow up immediately after procedure | 
| Patient Tolerance | Patient tolerance to the procedure measured by 10-points visual analogue scale (VAS) after the flexible cystoscopy. VAS from 0= minimum discomfort and 10=maximum discomfort. | follow up immediately after procedure | 
| Adverse events | Adverse events evaluation during and immediately after procedure | follow up immediately after procedure | 
| Adverse events | Adverse events from discharge up to 7 days post-procedure (follow-up call) | follow-up at 7 days after procedure |