HealthyNCT00998842
Comparison of a Novel 12-Lead Wireless Electrocardiogram (ECG) and a Standard Wired ECG
An observational study of Healthy, run by University of Oklahoma at 1 site in United States.
Trial summary
To determine if there is a difference between wireless ECG and wired ECG findings. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Recom Model 100 and GE 5000 ECG Monitor System
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Nov 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy individuals Age 18-64
Who may be able to join
- Healthy individuals, AND
- Age 18-64
Who cannot join
- Pregnant women,
- Prisoners,
- Have known cardiovascular disease, OR
- Do not pass the PAR-Q and/or show baseline ECG abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Novel 12-Lead Wireless ECG and a Standard Wired ECG
To determine if there is a difference between wireless ECG and wired ECG findings.
Read the 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.
- Conditions
- Healthy
- Being tested
- Recom Model 100, GE 5000 ECG Monitor System
- Keywords
- ECG, EKG, healthy subjects, electrocardiography, ambulatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recom Model 100Device
Battery Operated, Ambulatory, Digital Wireless ECG Monitor System
GE 5000 ECG Monitor SystemDevice
Wired ECG system
| Study group | Role | What they receive |
|---|---|---|
| healthy subjects | five male, five female, ages 18-64 Receives: Device: Recom Model 100; Device: GE 5000 ECG Monitor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998842
- Sponsor's protocol ID
- OU IRB 14853
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 4 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Novel 12-Lead Wireless ECG and a Standard Wired ECG
- ClinicalTrials.gov ID
- NCT00998842
- Acronym / sponsor ID
- OU IRB 14853
- Conditions
- Healthy
- Keywords
- ECG, EKG, healthy subjects, electrocardiography, ambulatory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma State University Center for Health Sciences
- Study start
- Oct 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy subjects | – | Device: Recom Model 100, Device: GE 5000 ECG Monitor Systemfive male, five female, ages 18-64 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy individuals Age 18-64
Key inclusion criteria (2 listed)
- Healthy individuals, AND
- Age 18-64
Key exclusion criteria (4 listed)
- Pregnant women,
- Prisoners,
- Have known cardiovascular disease, OR
- Do not pass the PAR-Q and/or show baseline ECG abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recom Model 100Battery Operated, Ambulatory, Digital Wireless ECG Monitor System | Device | healthy subjects |
| GE 5000 ECG Monitor SystemWired ECG system | Device | healthy subjects |
Primary outcome
ECG recordings from the wireless system will be equivalent to recordings from the standard wired system.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG recordings from the wireless system will be equivalent to recordings from the standard wired system. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2009.