MCG Discovery Study in Emergency Departments

October 17, 2025 updated by: SB Technology, Inc.

Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)

This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
  • Can provide written consent

Exclusion Criteria:

  • Presents to ED with ST-Elevation Myocardial Infarction (STEMI)
  • Presents to ED with Atrial Fibrillation
  • Clear non-ischemic cause for symptoms (i.e. trauma)
  • Active thoracic metal implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sponsor MCG device
All participants will receive a scan from the Sponsor MCG device
Device: Sponsor MCG device
unshielded device measuring cardiac magnetic fields

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% analyzable Sandbox MCG data
Time Frame: during the procedure (MCG scan)
% Sandbox MCG data collected and suitable for analysis
during the procedure (MCG scan)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sandbox MCG safety
Time Frame: 30 days
Device-related adverse events
30 days
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Time Frame: during the procedure (MCG scan)
Signal Noise Ratio of ECG features
during the procedure (MCG scan)
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Time Frame: during the procedure (MCG scan)
t-wave field maximum angle
during the procedure (MCG scan)
Characterization of scan results that may differentiate between high risk and low risk ACS patients
Time Frame: during the procedure (MCG scan)
heartbeats needed to obtain signal
during the procedure (MCG scan)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SB Technology, Inc.

Investigators

  • Study Director: Kit Yee Au-Yeung, PhD, SB Technology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Actual)

June 9, 2025

Study Completion (Actual)

July 8, 2025

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Estimated)

October 21, 2025

Last Update Submitted That Met QC Criteria

October 17, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-ACS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NSTEMI - Non-ST Segment Elevation MI

Clinical Trials on Sponsor MCG device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe