Health Volunteer Validation StudyViVUSNCT02975050
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
An observational study of Health Volunteer Validation Study, run by Zoll Medical Corporation.
Trial summary
This study has the following objective: To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects. The μ-Cor validation will be demonstrated at two body locations: 1. Side location (below left armpit) for study arm 1, and 2. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer Validation Study
- What is being tested?
- Location
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2016to 19 Jan 2017
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Subject is at least 21 years of age or older.
- Subject is willing and able to sign the Informed Consent Form.
- Subject is healthy, able and willing to complete all the preparation steps and study procedures.
Who cannot join
- Female subject with a known pregnancy or unsure about pregnancy status.
- Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Subjects with skin breakdown in areas where device placement is required.
- Subjects with chronic lung disease or asthma.
- Subjects with a history of cardiovascular diseases.
- Subjects who are diabetic.
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- Subjects living with kidney failure or dialysis.
- Subjects with a history of liver failure.
- Subjects with any known malignancy (i.e. cancer patients).
- Subjects with implanted devices in the thoracic region
About this study
This study has the following objective:
- To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
The μ-Cor validation will be demonstrated at two body locations:
- Side location (below left armpit) for study arm 1, and
- Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.
Read the detailed description
This study has the following objective:
- To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
The μ-Cor validation will be demonstrated at two body locations:
- Side location (below left armpit) for study arm 1, and
- Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.
- Conditions
- Health Volunteer Validation Study
- Being tested
- Location
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LocationOther
| Study group | Role | What they receive |
|---|---|---|
| Side location | u-Cor device will be applied on side location Receives: Other: Location | |
| Front location | u-Cor device will be applied on front location Receives: Other: Location |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory rate
The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).
Measured: Immediately
Posture
90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position
Measured: Immediately
Activity
μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.
Measured: Immediately
Heart Rate
Measured: Immediately
ECG
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study start28 Nov 2016
- Primary completion19 Jan 2017
- Study completion19 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Volunteer Validation StudyStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975050
- Sponsor's protocol ID
- 2016-KM-001
- Acronym
- ViVUS
- Status last verified
- Jul 2020
- First submitted
- 22 Nov 2016
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
- ClinicalTrials.gov ID
- NCT02975050
- Acronym / sponsor ID
- ViVUS / 2016-KM-001
- Conditions
- Health Volunteer Validation Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 19 Jan 2017 (actual)
- Study completion
- 19 Jan 2017 (actual)
- First posted
- 29 Nov 2016 (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.
This study has the following objective:
- To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
The μ-Cor validation will be demonstrated at two body locations:
- Side location (below left armpit) for study arm 1, and
- Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.
Detailed description
This study has the following objective:
- To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
The μ-Cor validation will be demonstrated at two body locations:
- Side location (below left armpit) for study arm 1, and
- Front location (upper left chest) for study arm 2 An FDA-cleared comparator device will be used to support the validation of the study device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Side location | – | Other: Locationu-Cor device will be applied on side location |
| Front location | – | Other: Locationu-Cor device will be applied on front location |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Subject is at least 21 years of age or older.
- Subject is willing and able to sign the Informed Consent Form.
- Subject is healthy, able and willing to complete all the preparation steps and study procedures.
Key exclusion criteria (10 listed)
- Female subject with a known pregnancy or unsure about pregnancy status.
- Subjects with allergies and/or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
- Subjects with skin breakdown in areas where device placement is required.
- Subjects with chronic lung disease or asthma.
- Subjects with a history of cardiovascular diseases.
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 |
|---|---|---|
| Location | Other | Front location, Side location |
Primary outcome
Respiratory rate
Time frame: Immediately
The difference between the μCor RR and the comparator RR will be lower than 2.8bpm (STD).
Posture
Time frame: Immediately
90% agreement between the positions (supine / reclined / upright) derived from μCor reporting and the known position
Activity
Time frame: Immediately
μCor output is provided as "active" and "not active". 90% correct classification of activity will be required of recordings.
Heart Rate
Time frame: Immediately
ECG
Time frame: Immediately
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 7 Jul 2020.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Volunteer Validation Study, run by Zoll Medical Corporation.
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 3 inclusion and 10 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Respiratory rate (time frame: Immediately). The study lists 5 primary outcomes in all. 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 7 Jul 2020.