BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study | NCT02133261

Studies
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study

NCT02133261

Sponsor

Bardy Diagnostics, Inc.

Status

Completed

Last Update Posted

Jun 26, 2014Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Cardiac Patients
ECG Monitoring

Interventions

Not provided

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

Jun 2014

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

Jun 2014

Primary Completion Date

Jun 2014Actual

Completion Date

Jun 2014Actual

First Submitted Date

May 6, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 8, 2014Estimated

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

Jun 25, 2014

Last Update Posted Date

Jun 26, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.

Detailed Description

The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.

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

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adhesive performance/durability	The study will evaluate adhesive performance/durability by evaluating the Signal Quality of ECG data on the subjects (5 men and 5 women) in accordance with the requirements of FDA's ECG Electrode Guidance (section 5.A.3)1 and the ANSI/AAMI EC-12 Disposable ECG electrode technical standard (sections 4.4 and 5.4)2.	7 days

Secondary Outcomes

Measure	Description	Time Frame
human factors	Skin comfort or discomfort Device comfort Device stability and contact	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cardiac patient volunteers (5 male and 5 female)

Exclusion Criteria:

skin rash or infection over the sternum
Sternal incision within 3 months from the date of enrollment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

cardiac patients followed at the study site's location

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gene Trobaugh, MD	EvergreenHealth	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
EvergreenHealth		Enumclaw	Washington	98022	United States