Blood PressureNCT06574113
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
An observational study of Blood Pressure, run by Perin Health Devices at 1 site in United States.
Trial summary
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP). 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?
- Perin Health Patch
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of male and female adult participants aged 18 years or older who are willing and able to provide informed consent and comply with the study procedures. Participants may be healthy or have comorbidities, so long as participants are members of any 'Special Population' as defined by the AAMI standards, including but not limited to pregnant individuals, children, and those with an arm circumference greater than 42 cm. Due to the nature of the investigational device, individuals with pacemakers or a history of reactions to medical adhesives may not participate.
Who may be able to join
- Adults aged 18 years or older,
- Willing and able to provide informed consent,
- Able to comply with study procedure.
Who cannot join
- Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference > 42 cm),
- Patient with a pacemaker,
- History of reactions to medical adhesives,
- Inability to comply with the study procedure,
- Non-English Speaker.
Trial locations and contacts
1 site in 1 country.
Valerie Rennoll, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
Perin Health Devices
Woodland Hills, California, 91364
Ian McLane, Ph.D., 818-606-9389, imclane@phasemargin.com
About this study
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
Read the detailed description
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.
- Conditions
- Blood Pressure
- Being tested
- Perin Health Patch
- Keywords
- Cuffless blood pressure, Wearable device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perin Health PatchDevice
The Perin Health Patch (PHP)is a multimodal wearable health patch, which combines auscultation, electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance (BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG (MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, and related unique parameters, that are used for the calculation of cuffless blood pressure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuffless blood pressure measurement performance
Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.
Measured: 3 months
Secondary outcomes (1)
Demographic performance variance
Determine any variations in performance on certain demographic groups, including subjects who are overweight, subjects with dark skin pigmentation, or subjects with comorbidities.
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 posted27 Aug 2024
- Study start15 Aug 2024
- Primary completion15 Oct 2024 (estimated)
- Study completion31 Dec 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perin Health Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ian M McLane, Ph.D., Principal investigator, Perin Health Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574113
- Sponsor's protocol ID
- PHD-001-24
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Access to the data will be restricted to the study team. If any future or secondary analysis is conducted by other investigators, a formal approval process will be undertaken, including the validation of proper training certificates and data use plans. Training, requests, and approvals will be maintained in Perin Health Devices' electronic quality management system (eQMS). PI McLane will be responsible for the oversight of the electronic and physical data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
- ClinicalTrials.gov ID
- NCT06574113
- Acronym / sponsor ID
- PHD-001-24
- Conditions
- Blood Pressure
- Keywords
- Cuffless blood pressure, Wearable device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Perin Health DevicesIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Aug 2024 (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.
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
Detailed description
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of male and female adult participants aged 18 years or older who are willing and able to provide informed consent and comply with the study procedures. Participants may be healthy or have comorbidities, so long as participants are members of any 'Special Population' as defined by the AAMI standards, including but not limited to pregnant individuals, children, and those with an arm circumference greater than 42 cm. Due to the nature of the investigational device, individuals with pacemakers or a history of reactions to medical adhesives may not participate.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older,
- Willing and able to provide informed consent,
- Able to comply with study procedure.
Key exclusion criteria (5 listed)
- Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference > 42 cm),
- Patient with a pacemaker,
- History of reactions to medical adhesives,
- Inability to comply with the study procedure,
- Non-English Speaker.
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 |
|---|---|---|
| Perin Health PatchThe Perin Health Patch (PHP)is a multimodal wearable health patch, which combines auscultation, electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance (BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG (MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, and related unique parameters, that are used for the calculation of cuffless blood pressure. | Device | – |
Primary outcome
Cuffless blood pressure measurement performance
Time frame: 3 months
Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.
1 secondary outcome
Demographic performance variance
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: Undecided. Access to the data will be restricted to the study team. If any future or secondary analysis is conducted by other investigators, a formal approval process will be undertaken, including the validation of proper training certificates and data use plans. Training, requests, and approvals will be maintained in Perin Health Devices' electronic quality management system (eQMS). PI McLane will be responsible for the oversight of the electronic and physical data.
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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.
Valerie Rennoll, Ph.D. contact
Ian M McLane, Ph.D. principal investigator
Perin Health Devices
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 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 3 inclusion and 5 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 28 Aug 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ian M McLane, Ph.D. (8186069389, imclane@phasemargin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cuffless blood pressure measurement performance (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 28 Aug 2024.