Pulse Oximeter Validation Study for the Perin Health Patch

Summary

The goal of this clinical trial is to evaluate the accuracy of the Perin Health Patch, a chest-worn pulse oximeter, in healthy adult volunteers by comparing its measurements to arterial blood gas analysis during controlled hypoxemia. This study will help determine whether the device meets the performance requirements of ISO 80601-2-61 and FDA 510(k) for SpO₂ measurement accuracy.

The main questions it aims to answer is whether the Perin Health Patch meet the required accuracy performance (Arms ≤ 3.5%) across the full range of 70-100% SaO₂ as defined by ISO 80601-2-61.

Participants will be healthy adults aged 18 to 50 years old, representing a diverse range of skin tones (including ≥15% with Fitzpatrick V or VI). Inclusion criteria require general good health and no chronic medical conditions. Exclusion criteria include obesity, cardiopulmonary conditions, hemoglobinopathies, pregnancy, and other safety considerations.

Participants will:

* Undergo screening and informed consent, including skin tone assessment using colorimetry and spectrophotometry.
* Be instrumented with the Perin Health Patch and reference pulse oximeters on randomized fingers.
* Undergo placement of an arterial catheter by a trained physician.
* Be asked to breathe through a mouthpiece while inspired oxygen concentration is gradually reduced under physician control to generate multiple plateaus of hypoxemia (70-100% SaO₂).
* Provide up to 30 arterial blood samples at steady-state hypoxemia levels to determine functional SaO₂ via co-oximetry.
* Be continuously monitored for SpO₂, heart rate, ECG, respiratory rate, and blood pressure during the study.
* Return to normoxia, and have the arterial line removed with hemostasis confirmed before discharge.

This protocol, based on UCSF's standard hypoxia lab procedures, has been used in over 3000 subjects and is designed to meet or exceed requirements of ISO 80601-2-61, ISO 14155, and FDA 510(k) standards.

Conditions

• Hypoxia

Interventions

DEVICE

Chest Worn Pulse Oximeter

The Perin Health Patch is a non-invasive, chest-worn wearable device designed to continuously monitor physiological signals, including photoplethysmography (PPG), oxygen saturation (SpO₂), electrocardiography (ECG), and other health metrics. In this study, the device will be evaluated for its ability to accurately measure SpO₂ during controlled hypoxemia in healthy adult volunteers. The SpO₂ values recorded by the Perin Health Patch will be compared against arterial oxygen saturation values (SaO₂) obtained via co-oximetry, following the UCSF Hypoxia Lab protocol aligned with ISO 80601-2-61 standards. This device integrates PPG and ECG sensors into a single chest-applied unit, distinguishing it from conventional finger or earlobe pulse oximeters. The intervention in this study is limited to the application and use of the device for data collection under clinically controlled oxygen saturation conditions.

Sponsors & Collaborators

• University of California, San Francisco

  collaborator OTHER

• Perin Health Devices

  lead INDUSTRY

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-27

Primary Completion

2025-05-28

Completion

2025-05-28

FDA Device

Yes

Countries

• United States

Study Locations