Trial Outcomes & Findings for Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study (NCT NCT05702515)
NCT ID: NCT05702515
Last Updated: 2025-04-08
Results Overview
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).
COMPLETED
27 participants
From time of consent through completion of chest x-ray
2025-04-08
Participant Flow
Willing adult patients scheduled to receive a PICC insertion using the G4 tip navigation system were screened and enrolled in the study.
Participant milestones
| Measure |
Adult Patients Scheduled to Receive a PICC Insertion
Adult patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system
Digital ECG Data Collection: synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Adult Patients Scheduled to Receive a PICC Insertion
Adult patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system
Digital ECG Data Collection: synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure
|
|---|---|
|
Overall Study
7 patients were excluded due to the inability to complete a chest radiograph.
|
7
|
Baseline Characteristics
Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study
Baseline characteristics by cohort
| Measure |
Adult Patients Scheduled to Receive a PICC Insertion
n=20 Participants
Adult patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system
Digital ECG Data Collection: synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure
|
|---|---|
|
Age, Customized
Subject 22 years old or older scheduled to receive a PICC using the VPS G4 and completion of xray
|
20 participants who completed chest xray
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From time of consent through completion of chest x-rayAll 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).
Outcome measures
| Measure |
Adult Patients Scheduled to Receive a PICC Insertion
n=20 Participants
Adult patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system
Digital ECG Data Collection: synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure
|
|---|---|
|
VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data
|
20 subjects who digital data was captured
|
Adverse Events
Adult Patients Scheduled to Receive a PICC Insertion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place