Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of the single-use Ambu® aScope™ 4 Cysto for removal of ureteral stents as compared to routine flexible reusable cystoscopes.

Detailed Description
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This study is a prospective, randomized, multi-center, post-market investigation of the effectiveness of Ambu® aScope™ 4 Cysto (single-use cystoscope) as compared to routine flexible reusable cystoscopes (standard of care) for ureteral stent removals. The investigation will include approximately 102 subjects (randomized at a 1:1 ratio).

Official Title
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Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy

Conditions
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Cystoscopy, Ureteral Stent

Intervention / Treatment
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* Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
* Device: Standard of care reusable cystoscope used for stent removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (male or female), ≥18 years old Patient undergoing routine flexible cystoscopy Patient with a ureteral stent in the urinary system that is ready to be removed. No active urinary tract infection Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol. Exclusion Criteria: History of prior bladder/urethral reconstructive surgery. History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes. Known unpassable urethral stricture Febrile patient with active urinary tract infection (UTI) Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) Subject with severe coagulopathy Patient is unable to read and/or understand study requirements Patient is unable or unwilling to provide written consent to participate in the study. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambu® aScope™ 4 Cysto<br>Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). | Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal<br>* Procedure using a single-use cystoscope for stent removal<br>|
| Active Comparator: Standard of Care (SOC)<br>Ureteral stent removal procedure performed with standard of care (reusable cystoscope). | Device: Standard of care reusable cystoscope used for stent removal<br>* Procedure using a reusable cystoscope for stent removal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting. | Stent removal procedural success rate with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance. | Procedure Date (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting to standard of care reusable scopes on scope performance. | Comparison of Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting to standard of care reusable scopes on scope performance as measured by procedure success rates, conversion rates, and device deficiency rates. | Procedure Date (Day 0) | 
| Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope. | Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope as measured by: Scope preparation for procedure Actual procedure time (insertion of cystoscope to removal of cystoscope) and Time to dispose of or prepare for reprocessing of cystoscopy equipment. | Procedure Date (Day 0) | 
| To evaluate the user experience during cystoscopic procedures. | Clinician satisfaction rated on a five-point scale (1-5) with 5 being the better outcome. Ease of insertion Ability to visualize anatomical landmarks and/or urothelium changes Perception of image quality Maneuverability in the bladder Scope articulation with tools in the working channel Visualization while tools are in the working channel | Clinician Questionnaire; completed within one (1) day of procedure date (Day 0). | 
| Safety Endpoints | Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure. All reported device and/or procedural related adverse events through ten (10) days post-procedure All Serious Adverse Events (SAEs) through 10 days post-procedure | 7-10 Days Post-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral Stent, aScope 4 Cysto, single-use cystoscope