Disposable vs Reusable Cystoscopes for Bladder Conditions

Recruiting at 3 trial locations

Overseen By Daniel S Laferriere, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Guangzhou Red Pine Medical Instrument Co., Ltd.

Disqualifiers: Urethral stricture, UTI, Coagulopathy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 30 minutes

Trial Summary

What is the purpose of this trial?

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.

Research Team

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults who need a urethral stent removed and may have conditions like bladder neck obstruction, stones in the bladder or kidneys, kidney disease, or bladder cancer. Participants should not have any health issues that would interfere with the procedure.

Inclusion Criteria

Subject is willing and able to sign informed consent and HIPAA authorization.

I do not have a current urinary tract infection.

I am scheduled for a routine bladder examination using a scope.

Exclusion Criteria

Known unpassable urethral stricture

I currently have a fever due to a urinary tract infection.

I currently have an acute infection such as urethritis, prostatitis, or epididymitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo cystoscopy using either the Redpine® Rflex endoTMHD Cystoscope or the site's standard of care reusable flexible cystoscope

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the cystoscopy procedure

4 to 10 days

1 follow-up contact (virtual or in-person)

Treatment Details

Interventions

• Cystoscopy with RedPine flexible disposable cystoscope

Trial Overview The study is testing if using a disposable cystoscope called RedPine Rflex endo High-Definition Cystoscope can speed up the time it takes to do a cystoscopy compared to standard reusable scopes typically used.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

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

Group II: Control Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Guangzhou Red Pine Medical Instrument Co., Ltd.

Lead Sponsor

Trials

1

Recruited

140+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

University of Texas Southwestern Medical Center

Collaborator

Trials

1,102

Recruited

1,077,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+