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

Guangzhou Red Pine Medical Instrument Co., Ltd.

Status: Withdrawn

Conditions: Bladder Cancer; Renal Stone; Renal Disease; Bladder Outlet Obstruction; Bladder Stone

Treatments: Device: Cystoscopy with RedPine flexible disposable cystoscope; Device: Cystoscopy with standard of care flexible reusable scope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06422312

USA001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Device: Cystoscopy with standard of care flexible reusable scope

Intervention

Experimental group

Description:

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

Treatment:

Device: Cystoscopy with RedPine flexible disposable cystoscope