WatchPAT SpO2 Validation Study

NCT06947447 | Completed FDA Device

• 1 other identifier: PR# 2024-598
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Validate the SpO2 accuracy of the WatchPAT compared to arterial blood CO-Oximetry

Conditions

Healthy

Keywords

Arterial Oxygen Saturation; Oxygen Saturation; WatchPAT; SpO2 sensor

Outcome Measures

Primary Outcomes (1)

• SpO2 Accuracy

  WatchPAT SpO2 accuracy performance over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.

  April-May 2025

Study Arms (1)

WatchPAT SpO2

Simultaneous data collection will be set up for the reference(s) and the device under test. The participants will have an arterial catheter placed in the radial artery to allow for simultaneous blood samples during stable plateaus of induced hypoxic levels. The WatchPAT will be placed on the finger(s) of both hands following the instructions for use. Each participant test is expected to take approximately 1.5 to 2 hours.

Device: No intervention

Interventions

No intervention DEVICE

Device

WatchPAT SpO2

Eligibility Criteria

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

Study Population

24 healthy male and female participants of any race, ranging in pigmentation from light to dark, aged 18-50 years old

You may qualify if:

• Participant must have the ability to understand and provide written informed consent.
• Participant is adult 18-50 years of age.
• Participant must be willing and able to comply with study procedures and duration.
• Participant is a non-smoker or who has not smoked within 2 days prior to the study.
• Male or female of any race.

You may not qualify if:

• Participant is considered as being morbidly obese (defined as BMI \>39.5)
• Compromised circulation (i.e., Raynaud's Syndrome), injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
• Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
• Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
• Participants with known respiratory conditions such as: (self-reported)
• uncontrolled / severe asthma,
• flu,
• pneumonia / bronchitis,
• shortness of breath / respiratory distress,
• unresolved respiratory or lung surgery,
• emphysema, COPD, lung disease
• Recent COVID with hospitalization
• Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
• high blood pressure: systolic \>140 mmHg or diastolic \>90 mmHg on 3 consecutive readings (reviewed during health screen)
• have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)

Sponsors & Collaborators

• Itamar-Medical, Israel: lead
• Element Materials Technology: collaborator

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Study Design

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

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: April 27, 2025
• Study Start: April 21, 2025
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)