NCT06574113

Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 85 (estimated)
• Sponsor: Perin Health Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
DEVICE	Perin Health Patch	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.

Timeline

• Start date: 2024-08-15
• Primary completion: 2024-10-15
• Completion: 2024-12-31
• First posted: 2024-08-27
• Last updated: 2024-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study