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

NCT ID: NCT01232933

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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Conditions

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Any Condition Requiring a PICC Placement

Keywords

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PICC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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VPS System

Use of navigational VPS system to place catheter

Group Type EXPERIMENTAL

VPS System

Intervention Type DEVICE

Use of the navigational VPS system during catheter placement

Interventions

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VPS System

Use of the navigational VPS system during catheter placement

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VasoNova, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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VasoNova, Inc.

Locations

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Georgetown University Hospital

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

Site Status

Countries

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United States

Other Identifiers

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TP-0120

Identifier Type: -

Identifier Source: org_study_id