MCG Discovery Study in Emergency Departments | NCT06095557

Studies
MCG Discovery Study in Emergency Departments

NCT06095557

Sponsor

SB Technology, Inc.

Status

Completed

Last Update Posted

Oct 21, 2025Actual

Enrollment

124Actual

Phase

Not Applicable

Conditions

ACS - Acute Coronary Syndrome
NSTEMI - Non-ST Segment Elevation MI

Interventions

Sponsor MCG device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 30, 2023Actual

Primary Completion Date

Jun 9, 2025Actual

Completion Date

Jul 8, 2025Actual

First Submitted Date

Oct 12, 2023

First Submission Date that Met QC Criteria

Oct 18, 2023

First Posted Date

Oct 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2025

Last Update Posted Date

Oct 21, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sponsor MCG device	Experimental	All participants will receive a scan from the Sponsor MCG device	Device: Sponsor MCG device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sponsor MCG device	Device	unshielded device measuring cardiac magnetic fields	Sponsor MCG device

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Sandbox MCG safety	Device-related adverse events	30 days
Characterization of scan results that may differentiate between high risk and low risk ACS patients	Signal Noise Ratio of ECG features

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kit Yee Au-Yeung, PhD	SB Technology, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome
D000072658	Non-ST Elevated Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided