Use of the VasoNova VPS System During PICC Placement in an Algorithm Confirmation Study Using Fluoroscopy
Not Applicable
Completed
- Conditions
- Any Condition Requiring a PICC Placement
- Interventions
- Device: VPS System
- Registration Number
- NCT01232933
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VPS System VPS System Use of navigational VPS system to place catheter
- Primary Outcome Measures
Name Time Method 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 participants are followed until catheter tip confirmation via fluoroscopy is completed which is on average one hour from procedure initiation
- Secondary Outcome Measures
Name Time Method The VPS will provide a blue bullseye indicator 80-90% of the time participants are followed until catheter tip confirmation is completed which is on average one hour from the start of the procedure
Trial Locations
- Locations (1)
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States