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

Completed · Not applicable

Conditions studied: Cystoscopy, Ureteral Stent

In brief

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.

Key facts

Study ID

NCT04829461

Run by

Ambu Inc.

People needed

102

Starts

2021-04-27

Expected to finish

2022-07-20

Last updated by the study team

2026-06-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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