Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy

VasoNova, Inc.83 enrolled

Overview

Subjects meeting study requirements will be consented and have their PICC catheter placed using navigational technology and the tip placement confirmed with radiographic imaging.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Any Condition Requiring a PICC Placement

Interventions

VPS SystemDEVICE

Use of the navigational VPS system during catheter placement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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

Time frame: participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation

Secondary Outcomes

The VPS will provide a blue bullseye indicator 80-90% of the time

Time frame: participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure

Data from ClinicalTrials.gov

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