Blood PressureBPNCT05735210
Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation
A study testing Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement in people with Blood Pressure, run by ChroniSense Medical Ltd. at 1 site in Germany.
Trial summary
Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2022to 1 Jul 2024
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be able to understand and provide an informed consent to participate.
- Subject must be willing and able to comply with the study procedures.
- Subject must be ≥ 50 and <80 years of age.
- At least 30% of subjects shall be male and at least 30% of subjects shall be female.
- Subject with an arm circumference in the range of the reference device cuff selection.
- Subject with a wrist circumference in the range of the IMD wrist size selection.
Who cannot join
- Subjects with physical characteristics that (e.g. tattoos, scarification, unusual bone structure) may prevent proper application of the device under test.
- Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
- Patients with known sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy, and trigeminy), and left bundle branch block.
- Patients with implantable defibrillators, pacemakers, neurostimulators, or other implantable or worn devices which may interfere with the Polso™ Watch or be affected by the Polso™ Watch in normal operation and use.
- Patients with known Parkinson's disease, essential tremor, convulsive disorders, or other disorder which prevents them from keeping their forearm at rest.
- Patients with known elevated levels of Methemoglobin (MetHb) or Carboxyhemoglobin (COHb), or with anomalous hemoglobin.
Show all 18Show fewer
- Patients with known severe anemia.
- Subjects with clinically apparent compromised circulation or peripheral vascular disease
- Subjects with clotting disorders or taking anticoagulants other than daily small doses of aspirin or similar
- Subjects that cannot tolerate sitting for up to 1 hour.
- Subjects that cannot perform the required blood pressure induced change procedure.
- Subject with a blood pressure (and other physiological parameters) demographic that has already been filled.
- Subjects with a known allergy to plastic, metals, and/or rubber.
- Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of non-invasive blood pressure cuff.
- Subjects who are pregnant.
- Subjects with BMI >35
- Subjects with BMI <20
- Subjects who gained or lost of >10% of their weight over a period of the last 6 months
Trial locations and contacts
1 site in 1 country.
Germany1 site
IPPMed - Institute for Pharmacology and Preventive Medicine GmbH
Cloppenburg, Low Saxony, 49661
About this study
Official title: Polso™ Watch BP Accuracy With BP Change Validation ChroniSense Study - IPPMed 1/2021
Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.
Read the detailed description
The purpose of this validation study is to assess, in an adult population, the three fundamental clinical tests:
- Blood pressure measurement accuracy ("accuracy test")
- Measurement accuracy after blood pressure change ("change test")
- Blood pressure measurement accuracy throughout the specified stability-period ("stability test") To provide evidence that the device can track changes in blood pressure, this study includes study conditions that specifically induce changes in blood pressure.
- Conditions
- Blood Pressure
- Being tested
- Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polso™ Watch blood pressure measurement compared to a reference blood pressure measurementDevice
The referenced blood pressure measurements are taken by dual auscultators.
| Study group | Role | What they receive |
|---|---|---|
| Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement | Experimental | Mean difference between the Polso™ Watch and reference measurement, and the associated standard deviation using data from the rest and induced change measurements following initialization Receives: Device: Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objectives: Main objective of the study is to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement over time frame of 1 month average.
Blood pressure measurements (units: mmHg) using the Polso™ Watch device will be taken and compared to reference blood pressure measurements taken at the same time using dual auscultatory blood pressure measurements, to show their accuracy and stability.
Measured: Through study completion, 1 month average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start26 Apr 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChroniSense Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IPPMed, Institute for Pharmacology and Preventive Medicine GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735210
- Sponsor's protocol ID
- Polso™ Watch BP Accuracy
- Acronym
- BP
- Status last verified
- Mar 2024
- First submitted
- 29 Jan 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polso™ Watch BP Accuracy With BP Change Validation ChroniSense Study - IPPMed 1/2021
- ClinicalTrials.gov ID
- NCT05735210
- Acronym / sponsor ID
- BP / Polso™ Watch BP Accuracy
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- ChroniSense Medical Ltd.Industry (pharma, biotech, devices)
- Collaborators
- IPPMed, Institute for Pharmacology and Preventive Medicine GmbH
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Feb 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.
Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.
Detailed description
The purpose of this validation study is to assess, in an adult population, the three fundamental clinical tests:
- Blood pressure measurement accuracy ("accuracy test")
- Measurement accuracy after blood pressure change ("change test")
- Blood pressure measurement accuracy throughout the specified stability-period ("stability test") To provide evidence that the device can track changes in blood pressure, this study includes study conditions that specifically induce changes in blood pressure.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement | Experimental | Device: Polso™ Watch blood pressure measurement compared to a reference blood pressure measurementMean difference between the Polso™ Watch and reference measurement, and the associated standard deviation using data from the rest and induced change measurements following initialization |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be able to understand and provide an informed consent to participate.
- Subject must be willing and able to comply with the study procedures.
- Subject must be ≥ 50 and <80 years of age.
- At least 30% of subjects shall be male and at least 30% of subjects shall be female.
- Subject with an arm circumference in the range of the reference device cuff selection.
Key exclusion criteria (18 listed)
- Subjects with physical characteristics that (e.g. tattoos, scarification, unusual bone structure) may prevent proper application of the device under test.
- Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
- Patients with known sustained or non-sustained ventricular/atrial arrhythmia (Ventricular tachycardia, supraventricular tachycardia, atrial fibrillation, bigeminy, and trigeminy), and left bundle branch block.
- Patients with implantable defibrillators, pacemakers, neurostimulators, or other implantable or worn devices which may interfere with the Polso™ Watch or be affected by the Polso™ Watch in normal operation and use.
- Patients with known Parkinson's disease, essential tremor, convulsive disorders, or other disorder which prevents them from keeping their forearm at rest.
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 |
|---|---|---|
| Polso™ Watch blood pressure measurement compared to a reference blood pressure measurementThe referenced blood pressure measurements are taken by dual auscultators. | Device | Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement |
Primary outcome
Primary Objectives: Main objective of the study is to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement over time frame of 1 month average.
Time frame: Through study completion, 1 month average
Blood pressure measurements (units: mmHg) using the Polso™ Watch device will be taken and compared to reference blood pressure measurements taken at the same time using dual auscultatory blood pressure measurements, to show their accuracy and stability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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?
A study testing Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement in people with Blood Pressure, run by ChroniSense Medical Ltd. at 1 site in Germany.
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 18 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 8 Mar 2024. 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 Germany. 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?
Results are not available in the source record.
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?
Primary Objectives: Main objective of the study is to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement over time frame of 1 month average. (time frame: Through study completion, 1 month average). 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 8 Mar 2024.