Blood Pressure MonitoringNCT07774169
Noninvasive Blood Pressure Validation Study
An observational study of Blood Pressure Monitoring and Blood Pressure, run by Perin Health Devices at 1 site in United States.
Trial summary
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and… Read more about this study
- Who is it for?
- Ages 22 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Monitoring, Blood Pressure
- What is being tested?
- Chest Worn Blood Pressure Monitor
- Type of treatment
- Medical device
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 15 Jun 2026
- 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 22 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers 22 to 90 years of age recruited from the general community at three clinical laboratory sites in the United States (Colorado, California, and Illinois). Enrollment targeted the demographic distribution requirements of ISO 81060-2:2018/AMD 1:2020 and IEEE 1708:2014, including two age cohorts (22-50 and 51-90 years), blood pressure range distribution, at least 30% male and 30% female participants, BMI distribution (at least 20% overweight and 20% obese), and skin tone distribution (at least 25% each of Monk scale 1-4, 5-7, and 8-10).
Who may be able to join
- Participant must have the ability to read and understand English and provide written informed consent.
- Participant must be willing and able to comply with study procedures and duration.
- Participant is an adult 22 - 90 years of age.
- Participant must have an arm circumference in the range of the reference and calibration cuffs.
Who cannot join
- Participant is unwilling to provide informed consent.
- Participants with deformities or abnormalities that may prevent proper application of the DUT
- Female participants who self-reported as pregnant, or who are self-reported as trying to get pregnant.
- Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other sensors (self-reported)
- Participant's screening BP exceed Measurement Range of the device (Systolic: 80-230 mmHg, Diastolic: 40-130 mm Hg)
- Participants with known heart arrhythmias.
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- Participants with peripheral vascular disease.
- Participants with clotting disorders.
- History of bleeding disorders or personal history of prolonged bleeding from injury
- History of blood clots
- Hemophilia
- Participants that cannot tolerate sitting or standing for the duration of the study.
- Participant with a blood pressure demographic that has already been filled.
- Other known health conditions that will prevent safe participation in the study upon disclosure in health assessment form or verbally.
- Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and stethoscope. The patch readings were then compared to the standard readings to see how closely they match, following recognized international testing standards for blood pressure devices (ISO 81060-2 and IEEE 1708). Participants visited one of three study sites up to three times over about one week. At the final visit, participants also did light resistance band exercise to briefly raise their blood pressure and relaxation activities to lower it, so the patch could be tested while blood pressure was changing.
- Conditions
- Blood Pressure Monitoring, Blood Pressure
- Being tested
- Chest Worn Blood Pressure Monitor
- Keywords
- Blood pressure validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest Worn Blood Pressure MonitorDevice
The Perin Health Patch (PHP) is an investigational, battery powered, wearable physiological monitoring device with an adhesive patch and sensor module, applied to the upper left chest. Cuffless noninvasive blood pressure measurements from the device were compared to a reference sphygmomanometer (dual observer auscultation, same arm simultaneous method).
| Study group | Role | What they receive |
|---|---|---|
| Adult Validation Cohort | Adults 22 to 90 years of age meeting the demographic distribution requirements of ISO 81060-2:2018/AMD 1:2020 and IEEE 1708:2014, comprising two age cohorts (22-50 years and 51-90 years). All participants wore the Perin Health Patch and underwent simultaneous reference blood pressure measurements by dual observer auscultation on Day 1 (calibration and accuracy), Day 3 (accuracy), and Day 7 (accuracy and induced blood pressure change). Receives: Device: Chest Worn Blood Pressure Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1)
Mean error (mmHg) of the individual paired determinations between the device under test and the reference sphygmomanometer (dual observer auscultation, same arm simultaneous method), calculated separately for systolic and diastolic blood pressure across all participants per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: mean error ≤ ±5.0 mmHg.
Measured: Day 1 through Day 7 (visit window up to Day 9 per participant)
Standard Deviation of the Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1)
Standard deviation (mmHg) of the errors of the individual paired determinations between the device under test and the reference sphygmomanometer, calculated separately for systolic and diastolic blood pressure across all participants per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: standard deviation ≤ 8.0 mmHg.
Measured: Day 1 through Day 7 (visit window up to Day 9 per participant)
Standard Deviation of Averaged Paired Determinations Per Participant (ISO 81060-2 Criterion 2)
Standard deviation (mmHg) of the averaged paired determinations per participant, calculated separately for systolic and diastolic blood pressure per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: the standard deviation must not exceed the maximum permissible standard deviation as a function of the observed mean error, per Table 1 (Averaged subject data acceptance) of the standard.
Measured: Day 1 through Day 7 (visit window up to Day 9 per participant)
Device Accuracy During Induced Blood Pressure Change
Mean error and standard deviation (mmHg) of paired determinations between the device under test and the reference sphygmomanometer during induced blood pressure increase (isometric resistance band exercise) and induced blood pressure decrease (relaxation) procedures, evaluated per IEEE 1708:2014 (including Amendment 1, 2019) and ISO 81060-2:2018/AMD 1:2020.
Measured: Day 7 (final study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start15 Jan 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perin Health Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774169
- Sponsor's protocol ID
- PR 2025-653
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Blood Pressure Validation Study
- ClinicalTrials.gov ID
- NCT07774169
- Acronym / sponsor ID
- PR 2025-653
- Conditions
- Blood Pressure Monitoring, Blood Pressure
- Keywords
- Blood pressure validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Perin Health DevicesIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 19 Aug 2026 (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 test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff. Adults 22 to 90 years of age wore the patch while trained observers took blood pressure readings at the same time using a standard arm cuff and stethoscope. The patch readings were then compared to the standard readings to see how closely they match, following recognized international testing standards for blood pressure devices (ISO 81060-2 and IEEE 1708). Participants visited one of three study sites up to three times over about one week. At the final visit, participants also did light resistance band exercise to briefly raise their blood pressure and relaxation activities to lower it, so the patch could be tested while blood pressure was changing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Validation Cohort | – | Device: Chest Worn Blood Pressure MonitorAdults 22 to 90 years of age meeting the demographic distribution requirements of ISO 81060-2:2018/AMD 1:2020 and IEEE 1708:2014, comprising two age cohorts (22-50 years and 51-90 years). All participants wore the Perin Health Patch and underwent simultaneous reference blood pressure measurements by dual observer auscultation on Day 1 (calibration and accuracy), Day 3 (accuracy), and Day 7 (accuracy and induced blood pressure change). |
Who may qualify
- Ages
- 22 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers 22 to 90 years of age recruited from the general community at three clinical laboratory sites in the United States (Colorado, California, and Illinois). Enrollment targeted the demographic distribution requirements of ISO 81060-2:2018/AMD 1:2020 and IEEE 1708:2014, including two age cohorts (22-50 and 51-90 years), blood pressure range distribution, at least 30% male and 30% female participants, BMI distribution (at least 20% overweight and 20% obese), and skin tone distribution (at least 25% each of Monk scale 1-4, 5-7, and 8-10).
Key inclusion criteria (4 listed)
- Participant must have the ability to read and understand English and provide written informed consent.
- Participant must be willing and able to comply with study procedures and duration.
- Participant is an adult 22 - 90 years of age.
- Participant must have an arm circumference in the range of the reference and calibration cuffs.
Key exclusion criteria (15 listed)
- Participant is unwilling to provide informed consent.
- Participants with deformities or abnormalities that may prevent proper application of the DUT
- Female participants who self-reported as pregnant, or who are self-reported as trying to get pregnant.
- Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other sensors (self-reported)
- Participant's screening BP exceed Measurement Range of the device (Systolic: 80-230 mmHg, Diastolic: 40-130 mm Hg)
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 |
|---|---|---|
| Chest Worn Blood Pressure MonitorThe Perin Health Patch (PHP) is an investigational, battery powered, wearable physiological monitoring device with an adhesive patch and sensor module, applied to the upper left chest. Cuffless noninvasive blood pressure measurements from the device were compared to a reference sphygmomanometer (dual observer auscultation, same arm simultaneous method). | Device | Adult Validation Cohort |
Primary outcome
Mean Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1)
Time frame: Day 1 through Day 7 (visit window up to Day 9 per participant)
Mean error (mmHg) of the individual paired determinations between the device under test and the reference sphygmomanometer (dual observer auscultation, same arm simultaneous method), calculated separately for systolic and diastolic blood pressure across all participants per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: mean error ≤ ±5.0 mmHg.
Standard Deviation of the Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1)
Time frame: Day 1 through Day 7 (visit window up to Day 9 per participant)
Standard deviation (mmHg) of the errors of the individual paired determinations between the device under test and the reference sphygmomanometer, calculated separately for systolic and diastolic blood pressure across all participants per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: standard deviation ≤ 8.0 mmHg.
Standard Deviation of Averaged Paired Determinations Per Participant (ISO 81060-2 Criterion 2)
Time frame: Day 1 through Day 7 (visit window up to Day 9 per participant)
Standard deviation (mmHg) of the averaged paired determinations per participant, calculated separately for systolic and diastolic blood pressure per ISO 81060-2:2018/AMD 1:2020. Acceptance criterion: the standard deviation must not exceed the maximum permissible standard deviation as a function of the observed mean error, per Table 1 (Averaged subject data acceptance) of the standard.
Device Accuracy During Induced Blood Pressure Change
Time frame: Day 7 (final study visit)
Mean error and standard deviation (mmHg) of paired determinations between the device under test and the reference sphygmomanometer during induced blood pressure increase (isometric resistance band exercise) and induced blood pressure decrease (relaxation) procedures, evaluated per IEEE 1708:2014 (including Amendment 1, 2019) and ISO 81060-2:2018/AMD 1:2020.
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 19 Aug 2026.
- 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?
An observational study of Blood Pressure Monitoring and Blood Pressure, run by Perin Health Devices 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 15 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 19 Aug 2026. 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?
Mean Error of Paired Blood Pressure Determinations (ISO 81060-2 Criterion 1) (time frame: Day 1 through Day 7 (visit window up to Day 9 per participant)). The study lists 4 primary outcomes in all. 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 19 Aug 2026.