Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06422312
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
A Study Comparing a Disposable Flexible Cystoscope With Reusable Scopes in Adult Patients
Sponsor:
Guangzhou Red Pine Medical Instrument Co Ltd
Organization:
Guangzhou Red Pine Medical Instrument Co Ltd
Study Overview
Official Title:
Clinical Investigation to Evaluate the Effectiveness of the Redpine Disposable Scope Compared to Standard Reusable Scope for Flexible Cystoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the time required for a cystoscopy procedure in adult participants using the Redpine Rflex endotrademark High-Definition Cystoscope or the sites 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 endotrademark High-Definition Cystoscope and the sites standard of care reusable flexible cystoscope in adult study participants requiring cystoscopy for visualization of andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None