Peripheral ICCNCT05702515

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

An observational study of Peripheral ICC, run by Teleflex at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Peripheral ICC
What is being tested?: Digital ECG Data Collection
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 21 Jul 2023to 26 Jun 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Hospital
Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study

Read the detailed 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.

Conditions: Peripheral ICC
Being tested: Digital ECG Data Collection
Keywords: VPS, VPS G4, Vascular Positioning System G4, PICC navigation and tip confirmation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05702515
Study group	Role	What they receive
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 Receives: Other: Digital ECG Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: From time of consent through completion of chest x-ray

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 202326 Jun 2024

First posted27 Jan 2023
Study start21 Jul 2023
Primary completion26 Jun 2024
Study completion26 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral ICCStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05702515
Sponsor's protocol ID: 2022-03
Status last verified: Feb 2025
First submitted: 17 Jan 2023
Last updated: 8 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vascular Positioning System G4 Algorithm ECG Data Collection for Model Training Study, A Single Center Prospective Clinical Study
ClinicalTrials.gov ID: NCT05702515
Acronym / sponsor ID: 2022-03
Conditions: Peripheral ICC
Keywords: VPS, VPS G4, Vascular Positioning System G4, PICC navigation and tip confirmation
Study type: Observational
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: TeleflexIndustry (pharma, biotech, devices)
Collaborators: Duke University
Study start: 21 Jul 2023 (actual)
Primary completion: 26 Jun 2024 (actual)
Study completion: 26 Jun 2024 (actual)
First posted: 27 Jan 2023 (actual)
Results: Posted 8 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Adult male patients scheduled to receive a PICC insertion	–	Other: Digital ECG Data CollectionAdult male patients scheduled to receive a PICC insertion using the Vascular Positioning System G4 tip navigation system

Who may qualify

Ages: 21 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

Male

Key exclusion criteria (6 listed)

Female

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digital ECG Data Collectionsynchronized digital data collected from the G4 and ECG machines during the PICC insertion procedure	Other	Adult male patients scheduled to receive a PICC insertion

Primary outcome

VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data
Time frame: From time of consent through completion of chest x-ray
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).

Results and safety

Results posted to the registry on 8 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adult Patients Scheduled to Receive a PICC Insertion	27	20

Primary outcome: VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data

Time frame: From time of consent through completion of chest x-ray. Number. Unit: subjects who digital data was captured

Measure	Adult Patients Scheduled to Receive a PICC Insertion n = 20
Value	20

Adverse events

Time frame: Study conducted between June 2023- July 2024. Subjects were evaluated from the time they were consented through completion of the chest x-ray.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adult Patients Scheduled to Receive a PICC Insertion	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tatiana Puga, B.S.B. study director

Teleflex Inc

Deborah H Allen, PhD principal investigator

Duke University

Britt M Meyer, PhD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral ICC, run by Teleflex at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VPS G4 System Digital Data vs GE MAC 5500 Ecg Machine Data (time frame: From time of consent through completion of chest x-ray). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05702515.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.