Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy
NCT ID: NCT04829461
Last Updated: 2022-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2021-04-27
2022-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ambu® aScope™ 4 Cysto
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
Procedure using a single-use cystoscope for stent removal
Standard of Care (SOC)
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
Standard of care reusable cystoscope used for stent removal
Procedure using a reusable cystoscope for stent removal
Interventions
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Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
Procedure using a single-use cystoscope for stent removal
Standard of care reusable cystoscope used for stent removal
Procedure using a reusable cystoscope for stent removal
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Ambu A/S
INDUSTRY
Ambu Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Elizabeth Smith
Role: STUDY_DIRECTOR
Ambu Inc.
Locations
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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
Countries
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References
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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.
O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CIS-023
Identifier Type: -
Identifier Source: org_study_id
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