Cystoscopy, Ureteral Stent
Conditions
Keywords
Ureteral Stent, aScope 4 Cysto, single-use cystoscope
Brief summary
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
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).
Interventions
DEVICEAmbu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
Procedure using a single-use cystoscope for stent removal
DEVICEStandard of care reusable cystoscope used for stent removal
Procedure using a reusable cystoscope for stent removal
Sponsors
Ambu Inc.
Ambu A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult (male or female), ≥18 years old 2. Patient undergoing routine flexible cystoscopy 3. Patient with a ureteral stent in the urinary system that is ready to be removed. 4. No active urinary tract infection 5. Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol.
Exclusion criteria
1. History of prior bladder/urethral reconstructive surgery. 2. History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes. 3. Known unpassable urethral stricture 4. Febrile patient with active urinary tract infection (UTI) 5. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis) 6. Subject with severe coagulopathy 7. Patient is unable to read and/or understand study requirements 8. Patient is unable or unwilling to provide written consent to participate in the study. 9. Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Stent Removal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conversion Rate | Procedure date (day 0) | Rate of conversion from one cystoscope to another to successfully complete the procedure |
| Device Deficiency Rate | Procedure date (day 0) | Reported rate of device deficiencies. |
| Cumulative Procedure Time | 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. |
| Evaluation of User Experience | Clinician Questionnaire; completed within one (1) day of procedure date (Day 0). | 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 |
Countries
United States
Contacts
STUDY_DIRECTORElizabeth Smith
Ambu Inc.
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 58.17 Years STANDARD_DEVIATION 14.01 |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 48 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 1 Participants |
| Race/Ethnicity, Customized White | 85 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 8 / 51 | 6 / 51 |
| serious Total, serious adverse events | 0 / 51 | 1 / 51 |
Outcome results
None listed