NCT05702515

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Teleflex · Industry
• Sex: Male
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Peripheral ICC

Interventions

Type	Name	Description
OTHER	Digital ECG Data Collection	synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure

Timeline

• Start date: 2023-07-21
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2023-01-27
• Last updated: 2025-04-08
• Results posted: 2025-04-08

Locations

1 site across 1 country: United States