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

June 4, 2026 updated by: Ambu Inc.

Clinical Investigation to Evaluate the Effectiveness of the Ambu® aScope™ 4 Cysto With the Ambu® 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • The Pennsylvania State University and The Milton S. Hershey Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin-Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ambu® aScope™ 4 Cysto
Ureteral stent removal procedure performed with Ambu® aScope™ 4 Cysto (single-use cystoscope).
Device: Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal
Procedure using a single-use cystoscope for stent removal
Active Comparator: Standard of Care (SOC)
Ureteral stent removal procedure performed with standard of care (reusable cystoscope).
Device: Standard of care reusable cystoscope used for stent removal
Procedure using a reusable cystoscope for stent removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Procedure Date (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion Rate
Time Frame: Procedure date (day 0)
Rate of conversion from one cystoscope to another to successfully complete the procedure
Procedure date (day 0)
Device Deficiency Rate
Time Frame: Procedure date (day 0)
Reported rate of device deficiencies.
Procedure date (day 0)
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:

  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.
Procedure Date (Day 0)
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.

  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
Clinician Questionnaire; completed within one (1) day of procedure date (Day 0).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ambu Inc.

Collaborators

Ambu A/S

Investigators

  • Study Director: Elizabeth Smith, Ambu Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CIS-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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