Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 15, 2010
November 1, 2010
June 2010
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01232933 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Any Condition Requiring a PICC Placement
Device: VPS System
Use of the navigational VPS system during catheter placement
Experimental: VPS System
Use of navigational VPS system to place catheter
Intervention: Device: VPS System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
October 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01232933
TP-0120
No
Kim Tompkins, VP Regulatory and Clinical Research, VasoNova, Inc.
VasoNova, Inc.
Not Provided
Not Provided
VasoNova, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP