Ignite Creation Date:
2024-05-06 @ 9:46 AM
Last Modification Date:
2024-10-26 @ 12:19 PM
Study NCT ID:
NCT03066999
Status:
TERMINATED
Last Update Posted:
2019-07-30
First Post:
2017-02-08
Brief Title:
DirectVision for Urinary Catheterization
Sponsor:
The Pur Clinic
Organization:
The Pur Clinic
Study Overview
Official Title:
Assessment of the Effectiveness and Ease of Use of DirectVision- a Direct Visualization System for Urinary Catheterization Results of a Single Center Prospective Study
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There was no enough subject
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Center for Disease Control and Prevention CDC reports that one in four patients hospitalized in the United States is catheterized to void the bladder or monitor urinary output In the male population Dr Singh an urologist estimates that about 20 of catheterizations are difficult Driving a catheter blindly guessing whether to push the catheter forward or manipulate it to get around a point of resistance leads to the risk of injury which increases the more the catheter is manipulated Additional adverse events include urosepsis UTI and bladder perforation The standard of care treatment for patients with difficult urinary catheterization DUC is to proceed with a cystoscopic catheter placement or suprapubic tube placement
PercuVision has the only Foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals Moreover it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure
In this study the investigators plan on assessing the effectiveness and ease of use of the PercuVision DirectVision System device
PercuVision has the only Foley catheter with a micro-endoscope for visualization and navigation of the urethra for nurses and other qualified health care professionals Moreover it allows urologists to place a guidewire under direct vision rather than calling for a flexible cystoscope which is considered a minor procedure
In this study the investigators plan on assessing the effectiveness and ease of use of the PercuVision DirectVision System device
Detailed Description:
Routine placement of transurethral catheters can be challenging in some situations such as urethral strictures severe phimosis and false passages Intravaginal retraction of the urethral meatus can complicate Foley placement in postmenopausal females In men blind urethral procedures with mechanical or metal sounds without visual guidance or guidewire assistance are now discouraged due to the increased risk of urethral trauma and false passages
DirectVision is a new visually-guided catheterization device VGCD that uses a camera visual guide microendoscope within a triple lumen flexible urinary catheter with an angled tip essentially combining the functionality of a urinary catheter with a cystoscope DirectVision uses fiber-optic bundle of 6000 integrated fibers to provide illumination and transmit real-time video
Procedures done via flexible cystoscopy or DirectVision are covered by insurance including MedicaidMedicare
In this prospective study the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization
DirectVision is a new visually-guided catheterization device VGCD that uses a camera visual guide microendoscope within a triple lumen flexible urinary catheter with an angled tip essentially combining the functionality of a urinary catheter with a cystoscope DirectVision uses fiber-optic bundle of 6000 integrated fibers to provide illumination and transmit real-time video
Procedures done via flexible cystoscopy or DirectVision are covered by insurance including MedicaidMedicare
In this prospective study the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization
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