Blood PressureNCT03409861
'Wristband Device for the Measurement of Intermittent Blood Pressure and Other Physiological Signals
An observational study of Blood Pressure, run by Hillel Yaffe Medical Center.
Trial summary
A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Jan 2018
- 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
- Adult, Older adult
Study population: Male and females over the age of 18 years Patients who are already fitted with and invasive Arterial Line (A-Line)
Who may be able to join
- Signed written Institution approved Informed Consent Form (ICF)
- Male and Females over the age of 18 years
- Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
- Only subjects who are fitted with an invasive Arterial Line (A LINE)
- To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.
Who cannot join
- Subject who are unable to provide consent
- Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.
- Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Non-invasive, Non-Oscillometric Blood Pressure Band
A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.
Read the detailed description
The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.
The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.
The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors
- Conditions
- Blood Pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Monitoring
Wearing of a non invasive wristband to measure Blood Pressure
Measured: 30-60 seconds of a clean signal from the A-line monitor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (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.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Avraham Shotan, Prof, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409861
- Sponsor's protocol ID
- GuardLyff
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 24 Jan 2018
- 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 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive, Non-Oscillometric Blood Pressure Band
- ClinicalTrials.gov ID
- NCT03409861
- Acronym / sponsor ID
- GuardLyff
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Jan 2018 (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 wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.
Detailed description
The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.
The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.
The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and females over the age of 18 years Patients who are already fitted with and invasive Arterial Line (A-Line)
Key inclusion criteria (5 listed)
- Signed written Institution approved Informed Consent Form (ICF)
- Male and Females over the age of 18 years
- Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
- Only subjects who are fitted with an invasive Arterial Line (A LINE)
- To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.
Key exclusion criteria (3 listed)
- Subject who are unable to provide consent
- Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.
- Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Pressure Monitoring
Time frame: 30-60 seconds of a clean signal from the A-line monitor
Wearing of a non invasive wristband to measure Blood Pressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
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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.
Avraham Shotan, Prof principal investigator
Principal Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Hillel Yaffe Medical Center.
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 5 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: status not confirmed, as of the sponsor's last update on 24 Jan 2018. 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 Michal Binebaum (972(0)547299564, michal.binenbaum@guardlyff.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Monitoring (time frame: 30-60 seconds of a clean signal from the A-line monitor). 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 24 Jan 2018.