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

NCT05702515 | Completed Results

• 1 other identifier: 2022-03
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral ICC

Keywords

VPS; VPS G4; Vascular Positioning System G4; PICC navigation and tip confirmation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Digital ECG Data Collection OTHER

synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure

Adult male patients scheduled to receive a PICC insertion

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Male subject over the age of 21
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teleflex: lead
• Duke University: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Results Point of Contact

• Title: Deborah Hutch Allen
• Organization: Duke University

hutch.allen@duke.edu

919-681-4719

Study Officials

• Tatiana Puga, B.S.B.

  Teleflex Inc

  STUDY DIRECTOR

• Deborah H Allen, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Britt M Meyer, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 27, 2023
• Study Start: July 21, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: April 8, 2025
• Results First Posted: April 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)