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

Teleflex

Status

Completed

Conditions

Peripheral ICC

Treatments

Other: Digital ECG Data Collection

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05702515

2022-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

Male

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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