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

Completed

• Conditions: Peripheral ICC
• Interventions: Other: Digital ECG Data Collection

• Registration Number: NCT05702515
• Lead Sponsor: Teleflex

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-25
• Study First Posted: 2023-01-27
• Study Start: 2023-07-21
• Status Verified: 2024-01
• Primary Completion: 2024-06-26
• Study Completion: 2024-06-26
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult male patients scheduled to receive a PICC insertion	Digital ECG Data Collection	Adult male patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system

Primary Outcome Measures

Name	Time	Method
VPS G4 system digital data	During PICC insertion procedure	VPS G4 digital captured data recorded at 11.667 MHz measuring ISPTA.3 (mW/cm2) vs time (s).
Electrocardiograph digitally captured data	During PICC insertion procedure	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).

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States