Any Condition Requiring a PICC Placement
Conditions
Keywords
PICC
Brief summary
Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.
Interventions
DEVICEVPS System
Use of the navigational VPS system during catheter placement
Sponsors
VasoNova, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult with a PICC placement order
Exclusion criteria
* Pregnant or nursing * Abnormal ECG * Anatomic irregularities or history that would prevent proper placement * Subject does not consent to photography, release of data and x-ray confirmation * Subject does not understand or is not willing to sign informed consent for the VPS implant procedure and data release
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance target: the catheter tip will be located in the lower 1/3 of the SVC or at the cavoatrial junction as evaluated by fluoroscopy with a VPS bullseye at least 90% of the time | participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation |
Secondary
| Measure | Time frame |
|---|---|
| The VPS will provide a blue bullseye indicator 80-90% of the time | participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure |
Countries
United States
Outcome results
None listed