Blood PressureNCT04876664
Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers
A study testing measuring blood pressure with noninvasive blood pressure device in people with Blood Pressure, run by GE Healthcare.
Trial summary
A study to collect data recorded by devices for cNIBP evaluation purposes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- measuring blood pressure with noninvasive blood pressure device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Sep 2021
- Phase
- Interventional
- 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
Who may be able to join
- Healthy male or female, aged 18 years or older (≥18 years);
- Willing and able to give informed consent for participation in the study;
- Able and willing to comply with all the study requirements.
Who cannot join
- Who is pregnant or lactating;
- Who is a smoker;
- Who has consumed alcohol in the last 24 hours;
- Who has been previously diagnosed with Ataxia or balance disorder;
- Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
- Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
- Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers
A study to collect data recorded by devices for cNIBP evaluation purposes.
Read the detailed description
The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.
- Conditions
- Blood Pressure
- Being tested
- measuring blood pressure with noninvasive blood pressure device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measuring blood pressure with noninvasive blood pressure deviceDevice
To measure blood pressure in different circumstances with noninvasive blood pressure device
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory monitoring solution | Experimental | this study has only one arm Receives: Device: measuring blood pressure with noninvasive blood pressure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection of NIBP measurement
To collect data recorded by devices for cNIBP evaluation purposes.
Measured: through study completion, average of one day
Secondary outcomes (1)
Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues
The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues.
Measured: through study completion, an average of one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juha Pärkkä, Principal investigator, VTT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876664
- Sponsor's protocol ID
- 210080046
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers
- ClinicalTrials.gov ID
- NCT04876664
- Acronym / sponsor ID
- 210080046
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 6 May 2021 (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.
A study to collect data recorded by devices for cNIBP evaluation purposes.
Detailed description
The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory monitoring solution | Experimental | Device: measuring blood pressure with noninvasive blood pressure devicethis study has only one arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female, aged 18 years or older (≥18 years);
- Willing and able to give informed consent for participation in the study;
- Able and willing to comply with all the study requirements.
Key exclusion criteria (7 listed)
- Who is pregnant or lactating;
- Who is a smoker;
- Who has consumed alcohol in the last 24 hours;
- Who has been previously diagnosed with Ataxia or balance disorder;
- Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
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 |
|---|---|---|
| measuring blood pressure with noninvasive blood pressure deviceTo measure blood pressure in different circumstances with noninvasive blood pressure device | Device | Ambulatory monitoring solution |
Primary outcome
Data collection of NIBP measurement
Time frame: through study completion, average of one day
To collect data recorded by devices for cNIBP evaluation purposes.
1 secondary outcome
Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues
Time frame: through study completion, an average of one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
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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.
Juha Pärkkä principal investigator
VTT
Questions about this trial
What is this clinical trial studying?
A study testing measuring blood pressure with noninvasive blood pressure device in people with Blood Pressure, run by GE Healthcare.
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 7 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: status not confirmed, as of the sponsor's last update on 6 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juha Pärkkä (+35840-7530525, juha.parkka@vtt.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data collection of NIBP measurement (time frame: through study completion, average of one day). 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 May 2021.