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OpenTrials
Completed

NCT Number: NCT01232933

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

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

Completed

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Key information

Conditions

Any Condition Requiring a PICC Placement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VPS System

Device

Use of the navigational VPS system during catheter placement

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

VasoNova, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2010
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.