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

Not Applicable

Completed

• Conditions: Cystoscopy; Ureteral Stent
• Interventions: Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal; Device: Standard of care reusable cystoscope used for stent removal

• Registration Number: NCT04829461
• Lead Sponsor: Ambu Inc.

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).

Study Timeline

• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Study Start: 2021-04-27
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambu® aScope™ 4 Cysto	Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal	Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
Standard of Care (SOC)	Standard of care reusable cystoscope used for stent removal	Ureteral stent removal procedure performed with standard of care (reusable cystoscope).

Primary Outcome Measures

Name	Time	Method
The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.	Procedure Date (Day 0)	Stent removal procedural success rate with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance.

Secondary Outcome Measures

Name	Time	Method
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.	Procedure Date (Day 0)	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.
Safety Endpoints	7-10 Days Post-Procedure	Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure.; 1. All reported device and/or procedural related adverse events through ten (10) days post-procedure; 2. All Serious Adverse Events (SAEs) through 10 days post-procedure
To evaluate the user experience during cystoscopic procedures.	Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).	Clinician satisfaction rated on a five-point scale (1-5) with 5 being the better outcome.; 1. Ease of insertion; 2. Ability to visualize anatomical landmarks and/or urothelium changes; 3. Perception of image quality; 4. Maneuverability in the bladder; 5. Scope articulation with tools in the working channel; 6. Visualization while tools are in the working channel
Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.	Procedure Date (Day 0)	Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope as measured by: 1. Scope preparation for procedure; 2. Actual procedure time (insertion of cystoscope to removal of cystoscope) and; 3. Time to dispose of or prepare for reprocessing of cystoscopy equipment.

Trial Locations

Locations (3)

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, United States