Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-02 @ 5:27 AM
Study NCT ID:
NCT07027150
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2025-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Oximeter Validation Study for the Perin Health Patch
Sponsor:
Perin Health Devices
Organization:
Study Overview
Official Title:
Pulse Oximeter Validation Study for the Perin Health Patch
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: