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| Name | Class |
|---|---|
| Ambu A/S | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambu® aScope™ 4 Cysto | Experimental | Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). |
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| Standard of Care (SOC) | Active Comparator | Ureteral stent removal procedure performed with standard of care (reusable cystoscope). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal | Device | Procedure using a single-use cystoscope for stent removal |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Procedure Date (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Conversion Rate | Rate of conversion from one cystoscope to another to successfully complete the procedure | Procedure date (day 0) |
| Device Deficiency Rate | Reported rate of device deficiencies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Smith | Ambu Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University and The Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19076146 | Background | 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. | |
| 8081563 | Background | O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambu® aScope™ 4 Cysto | Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). |
| FG001 | Standard of Care (SOC) | Ureteral stent removal procedure performed with standard of care (reusable cystoscope). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 |
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| Standard of care reusable cystoscope used for stent removal | Device | Procedure using a reusable cystoscope for stent removal |
|
| 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:
| Procedure Date (Day 0) |
| Evaluation of User Experience | Clinician satisfaction rated on a five-point scale (1-5) with 5 being the better outcome.
| Clinician Questionnaire; completed within one (1) day of procedure date (Day 0). |
| University of Texas Southwestern Medical Center |
| Dallas |
| Texas |
| 75390 |
| United States |
| University of Wisconsin-Madison | Madison | Wisconsin | 53792 | United States |
| 19966704 | Background | Pillai 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. |
| 19660204 | Background | Gee 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. |
| 21887113 | Background | Kadi 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. |
| 22665966 | Background | Miner 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. |
| 15316522 | Background | Sokol 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. |
| 37565290 | Derived | Johnson 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambu® aScope™ 4 Cysto | Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). |
| BG001 | Standard of Care (SOC) | Ureteral stent removal procedure performed with standard of care (reusable cystoscope). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was measured in years | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Sex was defined as at birth | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race/ethnicity was obtained at inclusion | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Procedure Date (Day 0) |
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| Secondary | Conversion Rate | Rate of conversion from one cystoscope to another to successfully complete the procedure | Posted | Count of Participants | Participants | Procedure date (day 0) |
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| Secondary | Device Deficiency Rate | Reported rate of device deficiencies. | Posted | Count of Participants | Participants | Procedure date (day 0) |
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| Secondary | 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:
| Posted | Median | Inter-Quartile Range | seconds | Procedure Date (Day 0) |
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| Secondary | Evaluation of User Experience | Clinician satisfaction rated on a five-point scale (1-5) with 5 being the better outcome.
| 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 | Posted | Median | Inter-Quartile Range | Units on a scale | Clinician Questionnaire; completed within one (1) day of procedure date (Day 0). |
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The safety was evaluated from collection and analysis of the incidence and seriousness of all adverse events through day 10 post-procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ambu® aScope™ 4 Cysto | Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope). | 0 | 51 | 0 | 51 | 8 | 51 |
| EG001 | Standard of Care (SOC) | Ureteral stent removal procedure performed with standard of care (reusable cystoscope). | 0 | 51 | 1 | 51 | 6 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment | UTI requiring hospitalization |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | Non-systematic Assessment |
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| Pain/abdominal pain | General disorders | Non-systematic Assessment |
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| anejaculation | General disorders | Non-systematic Assessment |
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| Leg swelling/foot cramp | General disorders | Non-systematic Assessment |
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| Dysuria/problems with urination | Renal and urinary disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Lund Tietze, Senior Clinical Evaluation Specialist | Ambu | +45 22489120 | liti@ambu.com |
| Apr 13, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2020 | Apr 13, 2026 | ICF_001.pdf |
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| Male |
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| Black or African American |
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| Asian |
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| Unknown or not reported |
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| Not Hispanic or Latino |
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| Hispanic or Latino |
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