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Trial Title:
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients.
NCT ID:
NCT06422312
Condition:
Bladder Cancer
Bladder Stone
Bladder Outlet Obstruction
Renal Stone
Renal Disease
Conditions: Official terms:
Urinary Bladder Neck Obstruction
Urinary Bladder Calculi
Conditions: Keywords:
cystoscopy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Cystoscopy with RedPine flexible disposable cystoscope
Description:
Use of a disposable flexible cystoscope to visualize the urethra and bladder, take
biopsies, and remove stents.
Arm group label:
Intervention
Intervention type:
Device
Intervention name:
Cystoscopy with standard of care flexible reusable scope
Description:
Use of a reusable flexible cystoscope to visualize the urethra and bladder, take
biopsies, and remove stents
Arm group label:
Control
Summary:
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Pennsylvania State University
Address:
City:
Hershey
Zip:
17033
Country:
United States
Contact:
Last name:
Suzanne L Boltz, B.S.
Phone:
717-531-0003
Phone ext:
287502
Email:
UrologyResearch@pennstatehealth.psu.edu
Contact backup:
Last name:
Amogh Pande, M.S.
Phone:
717-531-5930
Email:
UrologyResearch@pennstatehealth.psu.edu
Investigator:
Last name:
Jay D Raman, MD
Email:
Principal Investigator
Facility:
Name:
UT Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Contact:
Last name:
Brett Johnson, MD
Phone:
214-645-8765
Email:
brett.johnson@utsouthwestern.edu
Contact backup:
Last name:
Sonobia Garrett, BS
Phone:
214-645-8482
Email:
Sonobia.Garrett@UTSouthwestern.edu
Investigator:
Last name:
Brett Johnson, MD
Email:
Principal Investigator
Facility:
Name:
University of Washington
Address:
City:
Seattle
Zip:
98195
Country:
United States
Investigator:
Last name:
John L Gore, MD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Guangzhou Red Pine Medical Instrument Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Collaborator:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
Penn State University
Agency class:
Other
Source:
Guangzhou Red Pine Medical Instrument Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06422312
