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NCT07027150 · ClinicalTrials.gov registry record
Pulse Oximeter Validation Study for the Perin Health Patch
A clinical trial, sponsored by Perin Health Devices.
- Completed
- Registry status
- 12
- Enrollment target
NCT07027150 is a clinical trial that has completed, run by Perin Health Devices. The registered enrollment target is 12 participants.
The verdict
NCT07027150 has completed, sponsored by Perin Health Devices.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Chest Worn Pulse Oximeter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-05-27 |
| Est. Completion | 2025-05-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07027150
The ClinicalTrials.gov registry entry for NCT07027150 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Perin Health Devices, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Chest Worn Pulse Oximeter is the first listed.
NCT07027150 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07027150 about?
NCT07027150 is a clinical study titled "Pulse Oximeter Validation Study for the Perin Health Patch". 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 perfor...
What is the current status of trial NCT07027150?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2025-05-27. Estimated completion is 2025-05-28.
What interventions are being tested in trial NCT07027150?
The interventions under investigation include: Chest Worn Pulse Oximeter (DEVICE).
Who is sponsoring clinical trial NCT07027150?
This trial is sponsored by Perin Health Devices, which has 5 total clinical trials registered on ClinicalTrials.gov.
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