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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 15, 2010
Last Updated Date	November 1, 2010
Start Date ^ICMJE	June 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 1, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01232933 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 1, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
Official Title ^ICMJE	Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Any Condition Requiring a PICC Placement
Intervention ^ICMJE	Device: VPS System Use of the navigational VPS system during catheter placement
Study Arm (s)	Experimental: VPS System Use of navigational VPS system to place catheter Intervention: Device: VPS System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	83
Completion Date	October 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01232933
Other Study ID Numbers ^ICMJE	TP-0120
Has Data Monitoring Committee	No
Responsible Party	Kim Tompkins, VP Regulatory and Clinical Research, VasoNova, Inc.
Study Sponsor ^ICMJE	VasoNova, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	VasoNova, Inc.
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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