NCT03066999

DirectVision for Urinary Catheterization

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: The Pur Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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 6,000 integrated fibers to provide illumination and transmit real-time video. Procedures done via flexible cystoscopy or DirectVision are covered by insurance (including Medicaid/Medicare). In this prospective study, the investigators plan on assessing the effectiveness and ease of use of DirectVision - A direct visualization system for urinary catheterization.

Conditions

• Urethral Diseases

Interventions

Type	Name	Description
PROCEDURE	Cystoscopy	Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)
DEVICE	DirectVision	Patients will assign to either Group DirectVision (catheter placement via DirectVision)

Timeline

• Start date: 2017-03-07
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2017-03-01
• Last updated: 2019-07-30
• Results posted: 2019-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study