An Exploratory Clinical Study Non-invasive Monitoring of Cardiac Outputs

Sponsor

Pulsify Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT05734664

Collaborator

KU Leuven (Other), Universitaire Ziekenhuizen KU Leuven (Other)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pulsify Medical aims at developing a sensor designed for the non-invasive, continuous and real-time monitoring of cardiac hemodynamics in patients at risk based on new transducer technology and artificial intelligence. It relies on real-time 3D greyscale ultrasound reconstruction of the LV myocardium. This medical device is still under development and the main objective of this clinical investigation is to gather data on the accuracy of the current version of the sensor developed by Pulsify Medical to further guide the development of the device. The data generated will not be used for conformity assessment and this single-center prospective study on 8 patients is therefore deemed appropriate for this purpose.

During the pretreatment visit, eligibility of the subjects for the investigation will be assessed. Once subjects are considered eligible and they have consented to participate in the investigation, the visit to perform the monitoring will be scheduled. An operator will then perform on each patient two scans with the Pulsify sensor. For accurate 3D reconstruction, the ECG and breathing cycle during the acquisition will also be recorded. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using regular ultrasound equipment used for medical examinations in the hospital. The data generated will then be used to compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound. The data will also enable to acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Output Measurements Healthy Subjects	Device: Pulsify sensor Device: State-of-the-art ultrasound equipment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Every subject will first undergo 2 scans with the Pulsify sensor. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment.Every subject will first undergo 2 scans with the Pulsify sensor. Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

An Exploratory Clinical Study for the Development of a Novel Ultrasound Transducer Technology Intended for Non-invasive Monitoring of Cardiac Outputs

Actual Study Start Date :

Oct 19, 2022

Actual Primary Completion Date :

Jan 23, 2023

Actual Study Completion Date :

Jan 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Scan with Pulsify sensor A trained operator will perform on each volunteer two scans with the Pulsify sensor. Both scans will have a different orientation of the sensor.	Device: Pulsify sensor A positioning system will move the 1X1 cm Pulsify sensor step-by-step over a marked area of 10x10 cm on the subjects' chest to record a complete 3D data set of the heart. For accurate 3D reconstruction, the ECG and breathing cycle are also recorded during the acquisition using commercially available devices (Bitalino HeartBIT + Respiration Sensor). From the 3D dataset of the heart, the end-systolic and end-diastolic volumes will be extracted automatically to calculate the cardiac output.
Experimental: Scan with state-of-the-art ultrasound equipment Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment.	Device: State-of-the-art ultrasound equipment A complete 2D and 3D ultrasound data set using a GE Vivid E95 ultrasound machine, version 203 (General Electric Healthcare, Chicago, IL, United States) will be recorded. All data will be processed offline with a specialized software packet (EchoPAC, version 203, General Electric Healthcare, Chicago, IL, United States

Arm

Intervention/Treatment

Experimental: Scan with Pulsify sensor

A trained operator will perform on each volunteer two scans with the Pulsify sensor. Both scans will have a different orientation of the sensor.

Device: Pulsify sensor

A positioning system will move the 1X1 cm Pulsify sensor step-by-step over a marked area of 10x10 cm on the subjects' chest to record a complete 3D data set of the heart. For accurate 3D reconstruction, the ECG and breathing cycle are also recorded during the acquisition using commercially available devices (Bitalino HeartBIT + Respiration Sensor). From the 3D dataset of the heart, the end-systolic and end-diastolic volumes will be extracted automatically to calculate the cardiac output.

Experimental: Scan with state-of-the-art ultrasound equipment

Immediately after acquisition with the Pulsify sensor, an echocardiographist will record a complete 2D and 3D ultrasound data set using a state-of-the-art equipment.

Device: State-of-the-art ultrasound equipment

A complete 2D and 3D ultrasound data set using a GE Vivid E95 ultrasound machine, version 203 (General Electric Healthcare, Chicago, IL, United States) will be recorded. All data will be processed offline with a specialized software packet (EchoPAC, version 203, General Electric Healthcare, Chicago, IL, United States

Outcome Measures

Primary Outcome Measures

Comparison Cardiac Output [During procedure (1 hour)]
Compare the accuracy of the Pulsify sensor for cardiac output measurements with state-of-the-art ultrasound.

Secondary Outcome Measures

Capture dataset [During procedure (1 hour)]
Acquire a dataset of ultrasound images taken with the Pulsify sensor technology in a manner that is very close to the image capture mechanism of Pulsify's final product. This dataset can be used for further image processing development.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy volunteers can participate in this study if they:

are aged over 18 years old
have no known cardiovascular diseases
are willing and able to comply with all investigation related procedures

Exclusion Criteria:

Volunteers with arrhythmias, PM or ICD
Volunteers with life supporting electronic devices (e.g. pacemakers)
Volunteers with bad echocardiographic windows
Volunteers post recent thorax surgery and open chest wounds
Volunteers with abnormal thorax configuration (COPD, scoliosis, pectus excavatum, etc.) on criteria for the selection of topics
Women in gestation
Women that are breastfeeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Leuven	Leuven	Vlaams-Brabant	Belgium	3000

Sponsors and Collaborators

Pulsify Medical
KU Leuven
Universitaire Ziekenhuizen KU Leuven

Investigators

Principal Investigator: Alexander Van De Bruaene, UZ Leuven
Principal Investigator: Lieven Herbots, Pulsify Medical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pulsify Medical

ClinicalTrials.gov Identifier:

NCT05734664

Other Study ID Numbers:

FIH_TechDemo1
CIV-22-03-03916

First Posted:

Feb 21, 2023

Last Update Posted:

Feb 21, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pulsify Medical

Ultrasound Cardiac Non-invasive

Study Results

No Results Posted as of Feb 21, 2023