NCT07027150

Pulse Oximeter Validation Study for the Perin Health Patch

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: Perin Health Devices · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study is designed to evaluate the oxygen saturation measurement performance of the Perin Health Patch, a chest-worn pulse oximeter, during controlled hypoxemia in healthy adult volunteers. The study is conducted using UCSF's standard protocol for pulse oximeter performance evaluation, which has historically informed FDA and ISO standards (including ISO 80601-2-61). The Perin Health Patch integrates photoplethysmography (PPG) and other sensing modalities into a wearable form factor intended for clinical and non-clinical monitoring settings. Participants will be enrolled to ensure demographic diversity, including representation across a wide spectrum of skin pigmentation, with a minimum of 15% of subjects having Fitzpatrick skin type V or VI. The study will control inspired gas concentrations to induce stable arterial oxygen saturation plateaus between 70% and 100%. These plateaus enable comparison of the device's displayed SpO₂ values to gold-standard SaO₂ values determined from arterial blood samples using co-oximetry. SpO₂ readings from the Perin Health Patch will be collected concurrently with FDA-cleared reference pulse oximeters placed on contralateral or adjacent fingers. Readings at each plateau will be compared to SaO₂ to assess device accuracy and bias across the range of hypoxemia. The study will follow ISO 80601-2-61 methodology, including at least 200 paired data points from a minimum of 10 subjects. Averaging times and perfusion indices will be documented for all devices. Data will be analyzed to determine root mean square error (Arms), bias, and standard deviation between device SpO₂ and co-oximeter SaO₂ readings. The results will be used to assess whether the Perin Health Patch meets regulatory performance requirements for oxygen saturation monitoring and to support future regulatory submissions. This study does not involve randomization to different treatments or control arms. All participants undergo the same measurement protocol. No investigational treatments are administered. Safety protocols, including continuous vital sign monitoring and immediate availability of emergency medical care, are employed throughout the study.

Conditions

• Hypoxia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-27
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2025-06-18
• Last updated: 2025-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study