HealthyNCT05673174
Avicena LVDP Validation Study in Healthy Volunteers
An observational study of Healthy, run by Ventric Health, LLC at 1 site in United States.
Trial summary
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Non-Invasive Estimation of Left Ventricular Diastolic Pressure
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2022to 30 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers, no history of Heart Disease.
Who may be able to join
- Adult subjects >21 years of age.
- No known significant health problems.
- Willing and able to participate in all study evaluations.
- Ability to understand and sign informed consent.
Who cannot join
- Open skin lesions at the site of Vivio application / examination.
- Inability to obtain brachial artery blood pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
- Conditions
- Healthy
- Being tested
- Non-Invasive Estimation of Left Ventricular Diastolic Pressure
- Keywords
- left ventricular diastolic pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Estimation of Left Ventricular Diastolic PressureDiagnostic test
Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP
What is being measured
The primary outcome is the main question the study is designed to answer.
To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start16 Jun 2022
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ventric Health, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673174
- Sponsor's protocol ID
- CP-0006
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05673174
- Acronym / sponsor ID
- CP-0006
- Conditions
- Healthy
- Keywords
- left ventricular diastolic pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Ventric Health, LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 6 Jan 2023 (actual)
- 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.
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers, no history of Heart Disease.
Key inclusion criteria (4 listed)
- Adult subjects >21 years of age.
- No known significant health problems.
- Willing and able to participate in all study evaluations.
- Ability to understand and sign informed consent.
Key exclusion criteria (2 listed)
- Open skin lesions at the site of Vivio application / examination.
- Inability to obtain brachial artery blood pressure.
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 |
|---|---|---|
| Non-Invasive Estimation of Left Ventricular Diastolic PressureModified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP | Diagnostic test | – |
Primary outcome
To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.
Time frame: 3 months
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 6 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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 Ventric Health, LLC 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 4 inclusion and 2 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 6 Jan 2023. 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?
To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set. (time frame: 3 months). 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 6 Jan 2023.