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

This study has been completed.
Sponsor:
Information provided by:
VasoNova, Inc.
ClinicalTrials.gov Identifier:
NCT01232933
First received: June 15, 2010
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

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 Intervention
Any Condition Requiring a PICC Placement
Device: VPS System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy

Further study details as provided by VasoNova, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: June 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VPS System
Use of navigational VPS system to place catheter
Device: VPS System
Use of the navigational VPS system during catheter placement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01232933

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

No publications provided

Responsible Party: Kim Tompkins, VP Regulatory and Clinical Research, VasoNova, Inc.
ClinicalTrials.gov Identifier: NCT01232933     History of Changes
Other Study ID Numbers: TP-0120
Study First Received: June 15, 2010
Last Updated: November 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by VasoNova, Inc.:
PICC

ClinicalTrials.gov processed this record on October 19, 2014