An observational study in Blood Pressure, sponsored by Perin Health Devices. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Perin Health Devices · Observational
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).
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.
Perin Health Devices is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
Time frame: 3 months
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.
Time frame: 3 months
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Perin Health Devices