Clinical trial NCT04829461: Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy
Official title: Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystoscopy
Ureteral Stent
Keywords: Ureteral Stent
aScope 4 Cysto
single-use cystoscope
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
Collaborators: name: Ambu A/S
First posted: 2021-04-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.
timeFrame: Procedure Date (Day 0)
Secondary outcomes:
measure: Comparison of Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting to standard of care reusable scopes on scope performance.
timeFrame: Procedure Date (Day 0)
measure: Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.
timeFrame: Procedure Date (Day 0)
measure: To evaluate the user experience during cystoscopic procedures.
timeFrame: Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).
measure: Safety Endpoints
timeFrame: 7-10 Days Post-Procedure
Other outcomes:
Locations:
city: Hershey
country: United States
facility: The Pennsylvania State University and The Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: Ambu Inc.
name: Elizabeth Smith
role: STUDY_DIRECTOR
References:
citation: 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.
citation: O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.