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

Peripheral ICC Clinical Trial

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

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Peripheral ICC

• NCT number: NCT05702515
• Study type: Observational
• Source: Teleflex
• Status: Enrolling by invitation
• Start date: July 21, 2023
• Completion date: August 15, 2024