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Procedure

Disposable vs Reusable Cystoscopes for Bladder Conditions

N/A
Waitlist Available
Led By Yair Lotan, MD
Research Sponsored by Guangzhou Red Pine Medical Instrument Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient undergoing routine flexible cystoscopy
No active urinary tract infection
Must not have
Febrile patient with active urinary tract infection (UTI)
Subjects with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 10 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare how long it takes to perform a cystoscopy procedure using a new high-definition cystoscope called Redpine® Rflex endo(trademark) and a standard reusable flexible cyst

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for this device, typical risks of cystoscopy may include discomfort during urination, blood in urine, urinary tract infections, and rarely more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a routine bladder examination using a scope.
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I do not have a current urinary tract infection.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have a fever due to a urinary tract infection.
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I currently have an acute infection such as urethritis, prostatitis, or epididymitis.
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I have a severe blood clotting disorder.
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I am pregnant or can become pregnant and refuse to test or use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 10 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cumulative Procedure Time
Secondary study objectives
Device Failure Rate
Participant comfort during the procedure
RedPine Cystoscope Conversion Rate
+1 more
Other study objectives
Safety Endpoints

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants in this arm will receive cystoscopy using the Redpine® Rflex endoTMHD Cysto scope.
Group II: ControlActive Control2 Interventions
Participants in this arm will receive cystoscopy using the clinic's standard of care flexible reusable cystoscope of the urologist's choice.

Find a Location

Who is running the clinical trial?

University of WashingtonOTHER
1,815 Previous Clinical Trials
1,912,908 Total Patients Enrolled
Guangzhou Red Pine Medical Instrument Co., Ltd.Lead Sponsor
University of Texas Southwestern Medical CenterOTHER
1,081 Previous Clinical Trials
1,056,193 Total Patients Enrolled
~47 spots leftby Jan 2025
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