A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.

April 1, 2025 updated by: Yair Lotan, MD, Guangzhou Red Pine Medical Instrument Co., Ltd.

Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy.

This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope or the site's standard of care reusable flexible cystoscope in participants requiring urethral stent removal.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This randomized study will compare the cumulative procedure time between cystoscopy performed with the Redpine® Rflex endo(trademark) High-Definition Cystoscope and the site's standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of and/or intervention on the urinary bladder. The study will evaluate the user experience and product performance during cystoscopic procedures. Participant experience, tolerance to the procedure, and any differences in adverse events between disposable and reusable scope will be evaluated. The hypothesis is that the RedPine cystoscope will perform as well as reusable scopes and will have a shorter cumulative procedure time.

Study Type

Interventional

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
      • Hersey, Pennsylvania, United States, 17033
        • Pennsylvania State University
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female, aged at least 18 years old
  2. Patient undergoing routine flexible cystoscopy
  3. No active urinary tract infection
  4. Subject is willing and able to sign informed consent and HIPAA authorization.

Exclusion Criteria:

  1. Known unpassable urethral stricture
  2. Febrile patient with active urinary tract infection (UTI)
  3. Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
  4. Subject with severe coagulopathy
  5. Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.
Device: Cystoscopy with standard of care flexible reusable scope
Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents
Experimental: Intervention
Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.
Device: Cystoscopy with RedPine flexible disposable cystoscope
Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative Procedure Time
Time Frame: 30 minutes

To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the site's Standard of Care reusable flexible cystoscope as measured by:

  • Scope preparation for procedure
  • Actual procedure time (insertion of cystoscope to complete bladder examination) and
  • Time to dispose of or prepare for reprocessing of cystoscopy equipment.
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RedPine Cystoscope Conversion Rate
Time Frame: 30 minutes
Rate of conversion to a reusable cystoscope for those subjects randomized to the REDPINE cystoscope.
30 minutes
Device Failure Rate
Time Frame: 30 minutes
Device failure leading to a serious adverse event (SAE), termination of the procedure, or conversion to a reusable cystoscope.
30 minutes
Participant comfort during the procedure
Time Frame: 30 minutes

Participants will be interviewed using a questionnaire. Pain Intensity Please respond to the question by marking one box.

How would you rate your pain on average? 0 1 2 3 4 5 6 7 8 9 10 No pain Worst imaginable pain
30 minutes
User experience and product performance during cystoscopic procedures
Time Frame: within 24 hours

Physician satisfaction, rated on a five-point scale.

Scale Name Very Difficult Very Easy Outcome

Ease of insertion 1 5 5 = Better

Ability to visualize anatomical landmarks and/or urothelium changes 1 5 5 = Better

Perception of image quality 1 5 5 = Better

Maneuverability in the bladder 1 5 5 = Better

Overall Acceptability Yes/No
within 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoints
Time Frame: 4 to 10 days

Safety will be assessed based on the incidence rates of adverse events based on the seriousness and relatedness to the device and/or procedure.

1) All urologic adverse events, both device and procedure related, during the cystoscopy procedure through 7 (+/- 3) days post-procedure.

The subject will be asked if they have had:

  1. any signs or symptoms of a UTI

  2. any untoward effects post-procedure, including by not limited to

    1. gross hematuria last longer than 3 days post-procedure
    2. pain with urination lasting longer than 3 days post-procedure
    3. cloudy urine noted greater than one day post-procedure

    4. fever/chills or a diagnosis of UTI or other illness within the time since the cystoscopic procedure.

      2) All reported device and/or procedural related adverse events through 7 (+/- 3) days post- procedure 3) All Serious Adverse Events (SAEs) through 7 (+/- 3) days post-procedure
4 to 10 days

Collaborators and Investigators

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

Sponsor

Guangzhou Red Pine Medical Instrument Co., Ltd.

Collaborators

University of Washington
University of Texas Southwestern Medical Center
Penn State University

Investigators

  • Principal Investigator: Yair Lotan, MD, UT Southwestern Medical Center

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 (Estimated)

October 1, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 20, 2024

Study Record Updates

Last Update Posted (Actual)

April 4, 2025

Last Update Submitted That Met QC Criteria

April 1, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USA001

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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