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| Name | Class |
|---|---|
| Duke University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital ECG Data Collection | Other | synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Male
Exclusion Criteria:
Female
Male subject over the age of 21
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Adult male patients scheduled to receive a PICC insertion using the G4 tip navigation system may be considered for participation in the study.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
Data collected simultaneously from the G4 system and a 12-lead ECG machine during PICC insertion in adult subjects will be used for refining the next generation G4 algorithm model.
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Willing adult patients scheduled to receive a PICC insertion using the G4 tip navigation system were screened and enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Adult patients scheduled to receive a PICC insertion using the G4 tip navigation system and completed a chest x-ray were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Age 22 years old and older |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | subjects who digital data was captured | From time of consent through completion of chest x-ray |
|
Study conducted between June 2023- July 2024. Subjects were evaluated from the time they were consented through completion of the chest x-ray.
Number of AE Number of SAE Number of UADE 0 0 0
There were no reported AE/SAE/UADE reported during this study due to the short nature of the study. The average time from consent to completion of the study was usually less than 3 hours.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Patients Scheduled to Receive a PICC Insertion | This was a single arm study evaluating consenting adult patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system being enrolled and evaluated. Digital ECG Data Collection, synchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure, was collected for all subjects enrolled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Hutch Allen | Duke University | 919-681-4719 | hutch.allen@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2024 | Feb 11, 2025 | Prot_SAP_000.pdf |
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| Number |
| participants who completed chest xray |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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