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

Ambu Inc.3 sites in 1 country102 target enrollmentApril 27, 2021

ConditionsCystoscopy Ureteral Stent

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cystoscopy
Sponsor: Ambu Inc.
Enrollment: 102
Locations: 3
Primary Endpoint: The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 27, 2021

End Date

July 20, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ambu Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult (male or female), ≥18 years old
•Patient undergoing routine flexible cystoscopy
•Patient with a ureteral stent in the urinary system that is ready to be removed.
•No active urinary tract infection
•Subject is willing and able to sign informed consent and HIPAA authorization and comply with requirements of the protocol.

Exclusion Criteria

•History of prior bladder/urethral reconstructive surgery.
•History of high-grade bladder cancer or carcinoma in-situ of the bladder, undergoing cystoscopy for follow-up/surveillance purposes.
•Known unpassable urethral stricture
•Febrile patient with active urinary tract infection (UTI)
•Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
•Subject with severe coagulopathy
•Patient is unable to read and/or understand study requirements
•Patient is unable or unwilling to provide written consent to participate in the study.
•Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not

Outcomes

Primary Outcomes

The success rate of the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance for stent removal procedures performed in the outpatient setting.

Time Frame: Procedure Date (Day 0)

Stent removal procedural success rate with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance.

Secondary Outcomes

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))
Safety Endpoints(7-10 Days Post-Procedure)
To evaluate the user experience during cystoscopic procedures.(Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).)
Comparison of the Cumulative Procedure Time between the Ambu® aScope™ 4 cysto and the site's SOC reusable flexible cystoscope.(Procedure Date (Day 0))