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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bladder Cancer Bladder Stone Bladder Outlet Obstruction Renal Stone Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Control

Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.

Group Type ACTIVE_COMPARATOR

Cystoscopy with standard of care flexible reusable scope

Intervention Type DEVICE

Use of a reusable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents

Intervention

Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.

Group Type EXPERIMENTAL

Cystoscopy with RedPine flexible disposable cystoscope

Intervention Type DEVICE

Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

Interventions

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Cystoscopy with RedPine flexible disposable cystoscope

Use of a disposable flexible cystoscope to visualize the urethra and bladder, take biopsies, and remove stents.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No