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

November 1, 2010 updated by: VasoNova, Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VPS System
Use of navigational VPS system to place catheter
Device: VPS System
Use of the navigational VPS system during catheter placement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VasoNova, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

June 15, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2010

Last Update Submitted That Met QC Criteria

November 1, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TP-0120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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