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OpenTrials
Completed

NCT Number: NCT04829461

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

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.

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Key information

Conditions

Cystoscopy Ureteral Stent

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Pennsylvania State University and The Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal

Device

Procedure using a single-use cystoscope for stent removal

Standard of care reusable cystoscope used for stent removal

Device

Procedure using a reusable cystoscope for stent removal

Primary outcomes

  1. Number of Participants With Successful Stent Removal

    Time frame: Procedure Date (Day 0)

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

    Primary outcome is number of participants with successful stent removal with the Ambu® aScope™ 4 Cysto and the Ambu® aView™ 2 Advance compared to the Standard of Care.

Secondary outcomes

  1. Conversion Rate

    Time frame: Procedure date (day 0)

    Rate of conversion from one cystoscope to another to successfully complete the procedure

  2. Device Deficiency Rate

    Time frame: Procedure date (day 0)

    Reported rate of device deficiencies.

  3. Cumulative Procedure Time

    Time frame: 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:

    • 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.

  4. Evaluation of User Experience

    Time frame: 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.

    • 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

Sponsors and collaborators

Lead sponsor

Ambu Inc.

Industry

Collaborators

  • Ambu A/S

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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