Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study

Study Overview
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Brief Summary
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The objective of this study is to collect intravascular and extravascular echocardiogram (ECG) data from subjects receiving peripherally inserted central catheters (PICC) while using the Vascular Positioning System G4 and a 12 lead ECG machine. The data obtained will be used to update the G4 algorithm.

Detailed Description
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This study seeks to collect synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure. A copy of the data will be downloaded from the G4 and ECG machines and submitted to the sponsor. Both the G4 and the ECG machine used for data collection in this study are FDA cleared/approved. Study Design: This is a single center prospective clinical study. All enrolled subjects will receive a 12-lead ECG during PICC insertion and a chest x-ray post insertion. ECG lead will be documented via photographic imaging. Duration of Subject Study Participation: Each subject's participation will start at the time of signing the informed consent and terminate upon completion of the x-ray.

Official Title
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Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study

Conditions
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Peripheral ICC

Intervention / Treatment
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* Other: Digital ECG Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male 21 years of age or older Scheduled for PICC insertion using the VPS G4 system Willing to allow thoracic photos to be obtained after ECG lead placement Exclusion Criteria: Female ˂ 21 years of age Patient has a pacemaker Patient condition precluding ECG use and lead placement Patient condition precluding radiographic imaging Unwilling to allow thoracic photos to be obtained after ECG lead placement

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult male patients scheduled to receive a PICC insertion<br>Adult male patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system | Other: Digital ECG Data Collection<br>* synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VPS G4 system digital data | VPS G4 digital captured data recorded at 11.667 MHz measuring ISPTA.3 (mW/cm2) vs time (s). | During PICC insertion procedure | 
| Electrocardiograph digitally captured data | Electrocardiograph digitally captured data recorded at a sample resolution of 4.88 μV/LSB @ 250 sps, 1.22 μV/LSB @ 500 sps and a frequency response of -3 dB @ 0.01 to 150 Hz vs time (s). | During PICC insertion procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VPS, VPS G4, Vascular Positioning System G4, PICC navigation and tip confirmation