CystoscopyNCT04829461
Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy
A study testing Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal in people with Cystoscopy and Ureteral Stent, run by Ambu Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystoscopy, Ureteral Stent
- What is being tested?
- Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Apr 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The Pennsylvania State University and The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
Official title: Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy
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.
Read the 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).
- Conditions
- Cystoscopy, Ureteral Stent
- Being tested
- Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal, Standard of care reusable cystoscope used for stent removal
- Keywords
- Ureteral Stent, aScope 4 Cysto, single-use cystoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removalDevice
Procedure using a single-use cystoscope for stent removal
Standard of care reusable cystoscope used for stent removalDevice
Procedure using a reusable cystoscope for stent removal
| Study group | Role | What they receive |
|---|---|---|
| Ambu® aScope™ 4 Cysto | Experimental | Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). Receives: Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal |
| Standard of Care (SOC) | Active comparator | Ureteral stent removal procedure performed with standard of care (reusable cystoscope). Receives: Device: Standard of care reusable cystoscope used for stent removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Procedure Date (Day 0)
Secondary outcomes (4)
Conversion Rate
Rate of conversion from one cystoscope to another to successfully complete the procedure
Measured: Procedure date (day 0)
Device Deficiency Rate
Reported rate of device deficiencies.
Measured: 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:
- 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.
Measured: Procedure Date (Day 0)
Evaluation of User Experience
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
Measured: Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start27 Apr 2021
- Primary completion15 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CystoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ambu Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ambu A/S
- Responsible party
- Sponsor
- Investigators
- Elizabeth Smith, Study director, Ambu Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829461
- Sponsor's protocol ID
- CIS-023
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2021
- Last updated
- 5 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.
PubMed 19076146O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
PubMed 8081563Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.
PubMed 19966704Gee JR, Waterman BJ, Jarrard DF, Hedican SP, Bruskewitz RC, Nakada SY. Flexible and rigid cystoscopy in women. JSLS. 2009 Apr-Jun;13(2):135-8.
PubMed 19660204Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.
PubMed 21887113Miner N, Harris V, Lukomski N, Ebron T. Rinsability of orthophthalaldehyde from endoscopes. Diagn Ther Endosc. 2012;2012:853781. doi: 10.1155/2012/853781. Epub 2012 May 16.
PubMed 22665966Sokol WN. Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cytoscopy. J Allergy Clin Immunol. 2004 Aug;114(2):392-7. doi: 10.1016/j.jaci.2004.04.031.
PubMed 15316522Johnson BA, Raman JD, Best SL, Lotan Y. Prospective Randomized Trial of Single-Use vs Reusable Cystoscope for Ureteral Stent Removal. J Endourol. 2023 Oct;37(10):1139-1144. doi: 10.1089/end.2023.0134.
PubMed 37565290
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy
- ClinicalTrials.gov ID
- NCT04829461
- Acronym / sponsor ID
- CIS-023
- Conditions
- Cystoscopy, Ureteral Stent
- Keywords
- Ureteral Stent, aScope 4 Cysto, single-use cystoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ambu Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ambu A/S
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 5 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambu® aScope™ 4 Cysto | Experimental | Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removalUreteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). |
| Standard of Care (SOC) | Active comparator | Device: Standard of care reusable cystoscope used for stent removalUreteral stent removal procedure performed with standard of care (reusable cystoscope). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removalProcedure using a single-use cystoscope for stent removal | Device | Ambu® aScope™ 4 Cysto |
| Standard of care reusable cystoscope used for stent removalProcedure using a reusable cystoscope for stent removal | Device | Standard of Care (SOC) |
Primary outcome
Number of Participants With Successful Stent Removal
Time frame: 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.
4 secondary outcomes
Conversion Rate
Time frame: Procedure date (day 0)
Device Deficiency Rate
Time frame: Procedure date (day 0)
Cumulative Procedure Time
Time frame: Procedure Date (Day 0)
Evaluation of User Experience
Time frame: Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19076146Samplaski MK, Jones JS. Two centuries of cystoscopy: the development of imaging, instrumentation and synergistic technologies. BJU Int. 2009 Jan;103(2):154-8. doi: 10.1111/j.1464-410X.2008.08244.x. Epub 2008 Dec 8.
- Background: PubMed 8081563O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
- Background: PubMed 19966704Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. doi: 10.12968/hmed.2009.70.10.44626.
- Background: PubMed 19660204Gee JR, Waterman BJ, Jarrard DF, Hedican SP, Bruskewitz RC, Nakada SY. Flexible and rigid cystoscopy in women. JSLS. 2009 Apr-Jun;13(2):135-8.
- Background: PubMed 21887113Kadi N, Menezes P. ABC of flexible cystoscopy for junior trainee and general practitioner. Int J Gen Med. 2011;4:593-6. doi: 10.2147/IJGM.S20267. Epub 2011 Aug 19.
- Background: PubMed 22665966Miner N, Harris V, Lukomski N, Ebron T. Rinsability of orthophthalaldehyde from endoscopes. Diagn Ther Endosc. 2012;2012:853781. doi: 10.1155/2012/853781. Epub 2012 May 16.
- Background: PubMed 15316522Sokol WN. Nine episodes of anaphylaxis following cystoscopy caused by Cidex OPA (ortho-phthalaldehyde) high-level disinfectant in 4 patients after cytoscopy. J Allergy Clin Immunol. 2004 Aug;114(2):392-7. doi: 10.1016/j.jaci.2004.04.031.
- Derived from this study: PubMed 37565290Johnson BA, Raman JD, Best SL, Lotan Y. Prospective Randomized Trial of Single-Use vs Reusable Cystoscope for Ureteral Stent Removal. J Endourol. 2023 Oct;37(10):1139-1144. doi: 10.1089/end.2023.0134.
- Individual participant dataSharing planned: No
Related trials for Cystoscopy
RecruitingPhase 3
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
Bladder Cancer
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
RecruitingObservational study
Exploration of Novel AI-enabled Blue Light Enhanced Cystoscopy
Bladder Cancer, Non-muscle Invasive Bladder Cancer
Not yet recruitingObservational study
Outcomes for IR and High Risk (HR) Non-muscle Invasive Bladder Cancer (NMIBC) and ctDNA-based Biomarkers for Response and Recurrence in Muscle Invasive Bladder Cancer (MIBC)
NMIBC, MIBC
Recruiting
To Establish the Safety and Effectiveness of the ALPFA GRAIL PFA System for Treating Symptomatic Benign Prostate Hyperplasia (BPH) Also Known as an Enlarged Prostate.
Benign Prostatic Hyperplasia (BPH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Smith study director
Ambu Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal in people with Cystoscopy and Ureteral Stent, run by Ambu Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Stent Removal (time frame: Procedure Date (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829461, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.