Skip to main content
OpenTrials
Completed

NCT Number: NCT05702515

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peripheral ICC

Age range

21 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital ECG Data Collection

Other

synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure

Primary outcomes

  1. VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data

    Time frame: From time of consent through completion of chest x-ray

    All subjects for this study had their ECG recorded by the VPS G4 and GE MAC 5500 simultaneously. VPS G4 digital captured data recorded at 11.667 MHz measuring ISPTA.3 (mW/cm2) vs Digitally captured data from the GE MAC 5500 ECG Machine 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).

Sponsors and collaborators

Lead sponsor

Teleflex

Industry

Collaborators

  • Duke University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.