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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01232933
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
VasoNova, Inc.

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.

Condition or disease Intervention/treatment
Any Condition Requiring a PICC Placement Device: VPS System

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
Study Start Date : June 2010
Primary Completion Date : September 2010
Study Completion Date : October 2010

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232933


Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
VasoNova, Inc.

Responsible Party: Kim Tompkins, VP Regulatory and Clinical Research, VasoNova, Inc.
ClinicalTrials.gov Identifier: NCT01232933     History of Changes
Other Study ID Numbers: TP-0120
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: November 2, 2010
Last Verified: November 2010

Keywords provided by VasoNova, Inc.:
PICC