Blood PressureNCT02641327
Monitoring Changes in Blood Pressure
An observational study of Blood Pressure, run by EarlySense Ltd. at 1 site in Israel.
Trial summary
The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- EarlySense (Passive monitoring)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2015to Nov 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients from 2 groups will be recruited: 1. Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke) 2. Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement
Who may be able to join
- Age 18 years and up
- Patients hospitalized that require stabilization of his/ her blood Pressure
- Is willing to sign the consent form.
- Group II: Patients hospitalized in Intensive Care
- Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements
- Patient or next of kin or legal guardian are willing to sign consent form
Who cannot join
- Age < 18 years
- Does not sleep on a mattress that allows placing EarlySense sensor under it
- Patient or next of kin or legal guardian is not willing to sign consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure
The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard clinical care.
Read the detailed description
The study objective is to collect data to assess the accuracy and reliability of Earlysense contactless monitoring for blood pressure monitoring vs. gold reference methods such as ABPM (Ambulatory blood pressure measurement) for patients hospitalized in Internal Medicine department and vs. Arterial Line measurements for patients hospitalized in ICU. In addition the collected data will be used to further enhance and improve the existing algorithms.
- Conditions
- Blood Pressure
- Being tested
- EarlySense (Passive monitoring)
- Keywords
- Inhospital patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarlySense (Passive monitoring)Device
Passive contact-free monitoring
| Study group | Role | What they receive |
|---|---|---|
| Internal ward | Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke) Receives: Device: EarlySense (Passive monitoring) | |
| ICU | Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement Receives: Device: EarlySense (Passive monitoring) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
Determine the accuracy of the EarlySense system to measure blood pressure in a contactless way: we would like to see what were the BP measurements in the Gold Standard Devices, compares to what the EarlySense System was measuring at the same time
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 posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2016
- Study completionNov 2016
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.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- EarlySense Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641327
- Sponsor's protocol ID
- ES-CLC-2015_Prot_1_BP
- Status last verified
- Sep 2016
- First submitted
- 14 Dec 2015
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure
- ClinicalTrials.gov ID
- NCT02641327
- Acronym / sponsor ID
- ES-CLC-2015_Prot_1_BP
- Conditions
- Blood Pressure
- Keywords
- Inhospital patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EarlySense Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Dec 2015 (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.
The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard clinical care.
Detailed description
The study objective is to collect data to assess the accuracy and reliability of Earlysense contactless monitoring for blood pressure monitoring vs. gold reference methods such as ABPM (Ambulatory blood pressure measurement) for patients hospitalized in Internal Medicine department and vs. Arterial Line measurements for patients hospitalized in ICU. In addition the collected data will be used to further enhance and improve the existing algorithms.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal ward | – | Device: EarlySense (Passive monitoring)Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke) |
| ICU | – | Device: EarlySense (Passive monitoring)Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 2 groups will be recruited: 1. Patients hospitalized in Internal Medicine unit with unstable blood pressure that need regulation/ stabilization of their blood pressure (e.g., CHF, post surgical, hypotension or Hypertension patients, patients with kidney failure, heart disease, stroke) 2. Patients hospitalized in intensive care with arterial line that allow continuous blood pressure measurement
Key inclusion criteria (6 listed)
- Age 18 years and up
- Patients hospitalized that require stabilization of his/ her blood Pressure
- Is willing to sign the consent form.
- Group II: Patients hospitalized in Intensive Care
- Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements
Key exclusion criteria (3 listed)
- Age < 18 years
- Does not sleep on a mattress that allows placing EarlySense sensor under it
- Patient or next of kin or legal guardian is not willing to sign consent form
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 |
|---|---|---|
| EarlySense (Passive monitoring)Passive contact-free monitoring | Device | ICU, Internal ward |
Primary outcome
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
Time frame: 3 months
Determine the accuracy of the EarlySense system to measure blood pressure in a contactless way: we would like to see what were the BP measurements in the Gold Standard Devices, compares to what the EarlySense System was measuring at the same time
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 1 Dec 2016.
- 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 Blood Pressure, run by EarlySense Ltd. at 1 site in Israel.
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 6 inclusion and 3 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 1 Dec 2016. 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 Israel. 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?
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices (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 1 Dec 2016.