Trial Outcomes & Findings for Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy (NCT NCT04829461)
NCT ID: NCT04829461
Last Updated: 2026-06-05
Results Overview
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.
COMPLETED
NA
102 participants
Procedure Date (Day 0)
2026-06-05
Participant Flow
Subjects indicated and scheduled for routine flexible cystoscopy with a ureteral stent in the urinary system were recruited. The first subject was enrolled (procedure performed) on the 27th of April 2021 and the last subject was enrolled on the 15th of July 2022. A total of 102 subjects were enrolled in the study. The number of subjects were distributed between the three sites.
Participant milestones
| Measure |
Ambu® aScope™ 4 Cysto
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy
Baseline characteristics by cohort
| Measure |
Ambu® aScope™ 4 Cysto
n=51 Participants
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 Participants
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.27 Years
STANDARD_DEVIATION 13.24 • n=20 Participants
|
56.07 Years
STANDARD_DEVIATION 14.56 • n=20 Participants
|
58.17 Years
STANDARD_DEVIATION 14.01 • n=40 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
40 Participants
n=20 Participants
|
45 Participants
n=20 Participants
|
85 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
50 Participants
n=20 Participants
|
48 Participants
n=20 Participants
|
98 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Procedure Date (Day 0)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.
Outcome measures
| Measure |
Ambu® aScope™ 4 Cysto
n=51 Participants
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 Participants
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Number of Participants With Successful Stent Removal
|
50 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Procedure date (day 0)Rate of conversion from one cystoscope to another to successfully complete the procedure
Outcome measures
| Measure |
Ambu® aScope™ 4 Cysto
n=51 Participants
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 Participants
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Conversion Rate
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Procedure date (day 0)Reported rate of device deficiencies.
Outcome measures
| Measure |
Ambu® aScope™ 4 Cysto
n=51 Participants
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 Participants
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Device Deficiency Rate
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Procedure Date (Day 0)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.
Outcome measures
| Measure |
Ambu® aScope™ 4 Cysto
n=51 Participants
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 Participants
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Cumulative Procedure Time
|
611 seconds
Interval 322.0 to 954.0
|
1105 seconds
Interval 900.0 to 1467.0
|
SECONDARY outcome
Timeframe: Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).Population: Individual clinician satisfaction with the use of the cystoscope was assessed within one working day after the procedure on a 5-point Likert scale ranging from (1) Very difficult to (5) Very easy. Image quality was rated from (1) Very poor to (5) Very good
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
Outcome measures
| Measure |
Ambu® aScope™ 4 Cysto
n=51 Participants
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 Participants
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Evaluation of User Experience
Maneuverability in the bladder
|
4 Units on a scale
Interval 3.0 to 4.0
|
4 Units on a scale
Interval 3.0 to 4.0
|
|
Evaluation of User Experience
Scope articulation with tools in the working channel
|
4 Units on a scale
Interval 2.0 to 4.0
|
4 Units on a scale
Interval 2.0 to 4.0
|
|
Evaluation of User Experience
Visualization while tools are in the working channel
|
4 Units on a scale
Interval 3.0 to 4.0
|
4 Units on a scale
Interval 3.0 to 4.0
|
|
Evaluation of User Experience
Ease of insertion
|
4 Units on a scale
Interval 3.0 to 4.0
|
4 Units on a scale
Interval 3.0 to 4.0
|
|
Evaluation of User Experience
Ability to visualize anatomical landmarks and/or urothelium changes
|
4 Units on a scale
Interval 3.0 to 4.0
|
4 Units on a scale
Interval 3.0 to 4.0
|
|
Evaluation of User Experience
Perception of image quality
|
4 Units on a scale
Interval 3.0 to 4.0
|
4 Units on a scale
Interval 3.0 to 4.0
|
Adverse Events
Ambu® aScope™ 4 Cysto
Standard of Care (SOC)
Serious adverse events
| Measure |
Ambu® aScope™ 4 Cysto
n=51 participants at risk
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 participants at risk
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
2.0%
1/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
Other adverse events
| Measure |
Ambu® aScope™ 4 Cysto
n=51 participants at risk
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
|
Standard of Care (SOC)
n=51 participants at risk
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
3.9%
2/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
2.0%
1/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
|
General disorders
Pain/abdominal pain
|
5.9%
3/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
2.0%
1/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
|
General disorders
anejaculation
|
0.00%
0/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
2.0%
1/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
|
General disorders
Leg swelling/foot cramp
|
2.0%
1/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
2.0%
1/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
|
Renal and urinary disorders
Dysuria/problems with urination
|
3.9%
2/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
3.9%
2/51 • The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
|
Additional Information
Linda Lund Tietze, Senior Clinical Evaluation Specialist
Ambu
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place