Expired Study
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Washington, District of Columbia 20007


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.


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


Study is Available At:


Original ID:

TP-0120


NCT ID:

NCT01232933


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

VasoNova, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

83


Enrollment Type:

Actual


Study Dates

Start Date:June 2010
Completion Date:October 2010
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:November 2010
Last Changed Date:November 1, 2010
First Received Date:June 15, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type: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 a
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:VPS System
Description:Use of the navigational VPS system during catheter placement
Arm Name:VPS System

Study Arms

Study Arm Type:Experimental
Arm Name:VPS System
Description:Use of navigational VPS system to place catheter

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:VasoNova, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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