Effectiveness of Ambu® aScope™ 4 Cysto With the aView™ 2 Advance for Flexible Cystoscopy

Cystoscopy Clinical Trial

Official title:

Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® aView™ 2 Advance for Flexible Cystoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04829461
• Other study ID #: CIS-023
• Status: Completed
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: September 2022
• Source: Ambu A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 20, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystoscopy
• Ureteral Stent

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	The Pennsylvania State University and The Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Ambu Inc.	Ambu A/S

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View Citation

O'Sullivan DC, Chilton CP. Flexible cystoscopy. Br J Hosp Med. 1994 Apr 6-19;51(7):340-5. Review. — View Citation

Pillai PL, Sooriakumaran P. Flexible cystoscopy: a revolution in urological practice. Br J Hosp Med (Lond). 2009 Oct;70(10):583-5. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.	Stent removal procedural success rate with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance.	Procedure Date (Day 0)
Secondary	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.	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 as measured by procedure success rates, conversion rates, and device deficiency rates.	Procedure Date (Day 0)
Secondary	Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.	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.	Procedure Date (Day 0)
Secondary	To evaluate the user experience during cystoscopic procedures.	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	Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).
Secondary	Safety Endpoints	Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure.; All reported device and/or procedural related adverse events through ten (10) days post-procedure; All Serious Adverse Events (SAEs) through 10 days post-procedure	7-10 Days Post-Procedure