Disposable vs Reusable Cystoscopes for Bladder Conditions

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two tools used for cystoscopy, a procedure to examine the bladder. The goal is to determine which tool allows for a faster procedure: the new disposable cystoscope (specifically, the RedPine flexible disposable cystoscope) or the standard reusable one. Individuals needing a cystoscopy to remove a urethral stent, without an active urinary tract infection, might be suitable candidates. Participants will use either the new tool or the standard one, and the trial will evaluate which performs best. As an unphased trial, this study offers participants the opportunity to contribute to advancements in medical tools and improve future cystoscopy procedures.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Redpine® Rflex endo(trademark) High-Definition Cystoscope is safe for cystoscopy procedures?

Research shows that disposable cystoscopes, such as the Redpine® Rflex endo High-Definition Cystoscope, are generally easy for patients to handle. These devices assist in bladder procedures. The study compares a new disposable version to a widely used reusable one, emphasizing safety as a key concern.

Although specific safety data from this study is not yet available, similar devices have been used in many procedures without major safety issues. The trial primarily focuses on comparing the devices' effectiveness, indicating that earlier evaluations have already tested the device for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the RedPine flexible disposable cystoscope for bladder conditions because it offers a more hygienic and potentially safer alternative to the traditional reusable cystoscopes. Unlike reusable scopes, which require thorough cleaning and sterilization between uses, disposable scopes are single-use, significantly reducing the risk of cross-contamination and infection. This innovation could streamline the procedure, save time, and enhance patient safety, making it an appealing option for both medical professionals and patients.

What evidence suggests that the RedPine flexible disposable cystoscope is effective for bladder conditions?

This trial will compare the RedPine flexible disposable cystoscope with the clinic's standard flexible reusable cystoscope. Research has shown that the RedPine flexible disposable cystoscope might speed up cystoscopy procedures compared to reusable ones. Early results suggest that disposable scopes can reduce the total procedure time. This is important because shorter procedures can lead to less discomfort and quicker recovery for patients. Although more research is needed to confirm these benefits, the initial findings are promising for those seeking a potentially faster and more convenient cystoscopy experience. ^{1 2 3 4 6}

Who Is on the Research Team?

Yair Lotan, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06422312

NCT06422312 | A Study Comparing a Disposable Flexible ... This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition Cystoscope.

2. ctv.veeva.com ctv.veeva.com/study/a-study-comparing-a-disposable-flexible-cystoscope-with-reusable-scopes-in-adult-patients

A Study Comparing a Disposable Flexible Cystoscope With ... This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) ...

3. withpower.com withpower.com/trial/phase-urinary-bladder-neck-obstruction-6-2024-70002

Disposable vs Reusable Cystoscopes for Bladder Conditions This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition ...

4. clin.larvol.com clin.larvol.com/trial-detail/NCT06422312

A Study Comparing a Disposable Flexible Cystoscope With ... To compare the Cumulative Procedure Time between cystoscopy performed with the Redpine® Rflex endo(trademark) High Definition (endoTMHD) Cysto scope and the ...

5. clinconnect.io clinconnect.io/trials/NCT06422312

A Study Comparing a Disposable Flexible Cystoscope With This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine® Rflex endo(trademark) High-Definition ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221158.pdf

Guangzhou Red Pine Medical Instrument Co., Ltd. Xiangfei Li ... This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy ...