DirectVision for Urinary Catheterization
Stopped early · Not applicable
Conditions studied: Urethral Diseases
In brief
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.
Key facts
- Study ID
- NCT03066999
- Run by
- The Pur Clinic
- People needed
- 5
- Starts
- 2017-03-07
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2019-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Any patient over 18 years with a standard indication for difficult urinary catheterization
You may not qualify if…
- Any patient younger than 18 years of age, pregnant patients
Where it is running
- South Lake Hospital — Clermont, Florida, United States
Full record on ClinicalTrials.gov
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