CompletedNot Applicable

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

United States102 participantsStarted 2021-04-27

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

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)

Trial details

NCT IDNCT04829461

SponsorAmbu Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-15

View on ClinicalTrials.gov More Cystoscopy trials