Pulse Oximeter Validation Study for the Perin Health Patch

NCT07027150 | Completed FDA Device

• 1 other identifier: PHD-25-002
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypoxia; Desaturation; Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

• Accuracy of Perin Health Patch SpO₂ Measurements Compared to Arterial Blood Gas SaO₂

  The primary outcome is the accuracy of the oxygen saturation (SpO₂) values reported by the Perin Health Patch compared to functional arterial oxygen saturation (SaO₂) measured by co-oximetry from arterial blood samples. Accuracy will be assessed according to ISO 80601-2-61 standards using root-mean-square error (Arms), bias (mean difference), and standard deviation. Measurements will be collected at multiple stable plateaus of oxygen saturation induced by adjusting inspired gas concentrations in a controlled laboratory setting. Each comparison will be made at steady-state conditions, verified by reference pulse oximeters and end-tidal gas analysis.

  During a single in-lab hypoxemia session lasting approximately 1 hour per participant

Study Arms (1)

Healthy Volunteer

This cohort includes healthy adult volunteers aged 18-50 who undergo controlled hypoxemia testing to evaluate the performance of the Perin Health Patch, a chest-worn pulse oximeter. Each participant will be fitted with the Perin Health Patch and one or more FDA-cleared reference pulse oximeters. Under the supervision of trained clinicians, inspired oxygen concentrations will be adjusted to achieve stable oxygen saturation plateaus between 70% and 100%. Arterial blood samples will be collected and analyzed via co-oximetry to determine true functional SaO₂ values. Device performance will be assessed by comparing the SpO₂ readings from the Perin Health Patch with these reference values in accordance with ISO 80601-2-61.

Device: Chest Worn Pulse Oximeter

Interventions

Chest Worn Pulse Oximeter DEVICE

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.

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of healthy adult volunteers between the ages of 18 and 50 years, recruited to ensure adequate demographic and skin tone diversity. At least 15% of participants will have Fitzpatrick skin types V or VI. All participants must be in good general health, with no history of chronic cardiovascular, pulmonary, hematologic, renal, or hepatic conditions. Volunteers are excluded if they have a body mass index (BMI) greater than 30, are current smokers, or have any contraindications to arterial line placement or hypoxia exposure. Pregnant or lactating individuals are also excluded. All participants must provide informed consent and be fully vaccinated against COVID-19. The population is limited to English-speaking individuals due to current protocol constraints.

You may qualify if:

• The subject is aged ≥18 and \<50.
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English (we are actively working to expand access to this study to subjects who prefer other languages)
• The subject has provided informed consent and is willing to comply with the study procedures

You may not qualify if:

• The subject is obese (BMI\>30).
• The subject has a known history of heart disease, lung disease, kidney or liver disease.
• Diagnosis of asthma, sleep apnea, or use of CPAP.
• Subject has diabetes.
• Subject has a clotting disorder.
• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
• The subject has any other serious systemic illness.
• The subject is a current smoker.
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
• The subject has a history of fainting or vasovagal response.
• The subject has a history of sensitivity to local anesthesia.
• The subject has a diagnosis of Raynaud's disease.
• The subject has unacceptable collateral circulation based on an exam by the investigator (Allen's test).
• The subject is pregnant, lactating or trying to get pregnant.
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.

Sponsors & Collaborators

• Perin Health Devices: lead
• University of California, San Francisco: collaborator

Study Sites (1)

UCSF Hypoxia Lab

San Francisco, California, 94133, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 18, 2025
• Study Start: May 27, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (1)