Electrocardiogram (ECG) Validation Study | NCT06414447

Studies
Electrocardiogram (ECG) Validation Study

NCT06414447

Sponsor

Huxley Medical, Inc.

Status

Unknown status

Last Update Posted

May 16, 2024Actual

Enrollment

15Estimated

Phase

Not provided

Conditions

Arrythmia

Interventions

Huxley Medical

Countries

Not provided

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

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2024Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

May 7, 2024

First Submission Date that Met QC Criteria

May 9, 2024

First Posted Date

May 16, 2024Actual

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

May 9, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Name	Type	Description	Arm Group Labels	Other Names
Huxley Medical	Diagnostic Test	diagnostic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the diagnostic Electrocardiogram (ECG) signal quality of the P, QRS and T wave deflections of the Sansa device to a reference standard Holter monitor		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA

18 years of age of older
Able to read, understand, and sign informed consent documentation willing to wear the Sansa device and 3-lead or 5-lead Holter monitor simultaneously for 24- hours
In the opinion of the investigator, subject is willing to comply with the protocol

EXCLUSION CRITERIA

Noted deformities of the chest (e.g., pronounced scarring, pectus carinatum) that would Interfere with sensor placement
broken or injured skin that would interfere with sensor placement, are known to experience adverse reactions to medical-grade adhesive
pacemaker dependent
females who are pregnant (self-reported)

Accepts Healthy Volunteers

Yes

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

subjects willing to participate in an ECG diagnostic evaluation

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jill Fricke	Contact	949-310-4697		jfricke@huxleymed.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided