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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Procedure using a single-use cystoscope for stent removal
Procedure using a reusable cystoscope for stent removal
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Number of Participants With Successful Stent Removal
The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting. Primary outcome is number of participants with successful stent removal with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance compared to the Standard of Care.
Time frame: Procedure Date (Day 0)
Conversion Rate
Rate of conversion from one cystoscope to another to successfully complete the procedure
Time frame: Procedure date (day 0)
Device Deficiency Rate
Reported rate of device deficiencies.
Time frame: Procedure date (day 0)
Cumulative Procedure Time
Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope as measured by: 1. Scope preparation for procedure 2. Actual procedure time (insertion of cystoscope to removal of cystoscope) and 3. Time to dispose of or prepare for reprocessing of cystoscopy equipment.
Time frame: Procedure Date (Day 0)
Evaluation of User Experience
Clinician satisfaction rated on a five-point scale (1-5) with 5 being the better outcome. 1. Ease of insertion 2. Ability to visualize anatomical landmarks and/or urothelium changes 3. Perception of image quality 4. Maneuverability in the bladder 5. Scope articulation with tools in the working channel 6. Visualization while tools are in the working channel
Time frame: Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).
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