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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05702515
• Other study ID #: 2022-03
• Status: Enrolling by invitation
• Start date: July 21, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: January 2024
• Source: Teleflex
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 25
• Est. completion date: August 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral ICC

Intervention

Other:
• Digital ECG Data Collection
synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Teleflex	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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