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

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

Study Overview

• Status: Completed
• Conditions: Peripheral ICC
• Intervention / Treatment: Other: Digital ECG Data Collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult male patients scheduled to receive a PICC insertion using the G4 tip navigation system may be considered for participation in the study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult male patients scheduled to receive a PICC insertion; Adult male patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system	Other: Digital ECG Data Collection; synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data	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).	From time of consent through completion of chest x-ray

Collaborators and Investigators

• Sponsor: Teleflex
• Collaborators: Duke University
• Investigators: Study Director: Tatiana Puga, B.S.B., Teleflex Inc; Principal Investigator: Deborah H Allen, PhD, Duke University; Principal Investigator: Britt M Meyer, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2023
• Primary Completion (Actual): June 26, 2024
• Study Completion (Actual): June 26, 2024

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: VPS; VPS G4; Vascular Positioning System G4; PICC navigation and tip confirmation
• Other Study ID Numbers: 2022-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data collected simultaneously from the G4 system and a 12-lead ECG machine during PICC insertion in adult subjects will be used for refining the next generation G4 algorithm model.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No