Teleflex
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.
Peripheral ICC
Digital ECG Data Collection
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 Type : | Observational |
| Estimated Enrollment : | 25 participants |
| Official Title : | Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study |
| Actual Study Start Date : | July 21, 2023 |
| Estimated Primary Completion Date : | July 15, 2024 |
| Estimated Study Completion Date : | August 15, 2024 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 21 Years |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Duke University Hospital
Durham, North Carolina, United States, 27710