Comparison of a Novel 12-Lead Wireless Electrocardiogram... | NCT00998842

Studies
Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG

NCT00998842

Sponsor

University of Oklahoma

Status

Completed

Last Update Posted

Nov 4, 2009Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Healthy

Interventions

Recom Model 100
GE 5000 ECG Monitor System

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 2009

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 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Oct 20, 2009

First Submission Date that Met QC Criteria

Oct 20, 2009

First Posted Date

Oct 21, 2009Estimated

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

Nov 3, 2009

Last Update Posted Date

Nov 4, 2009Estimated

Name	Class
Oklahoma State University Center for Health Sciences	OTHER

Description Module

Brief Summary

To determine if there is a difference between wireless ECG and wired ECG findings.

Detailed Description

The aim of the study is to compare ECG recordings from the Signalife Fidelity 100 Wireless 12-lead ECG Monitor System to that of the GE 5000 Wired 12-lead ECG Monitor System during rest and while walking. We hypothesize that ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy subjects		five male, five female, ages 18-64	Device: Recom Model 100 Device: GE 5000 ECG Monitor System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Recom Model 100	Device	Battery Operated, Ambulatory, Digital Wireless ECG Monitor System	healthy subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy individuals, AND
Age 18-64

Exclusion Criteria:

Pregnant women,
Prisoners,
Have known cardiovascular disease, OR
Do not pass the PAR-Q and/or show baseline ECG abnormalities.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Healthy individuals Age 18-64

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Family Medicine Clinic		Tulsa	Oklahoma	74120	United States