SpO2 Validation Study - All.Health Algo Oximeter Software

NCT07527000 | Recruiting FDA Device

• 1 other identifier: PR 2025-665
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical use of pulse oximeters has reduced the frequency and necessity of invasive arterial blood sampling and has helped to improve patient safety by providing continuous information to clinicians about patients' oxygenation status. all.health is dedicated to developing and applying innovative electronic medical solutions that improve patient care with the Algo Oximeter Software, to be used in applications for monitoring oxygen saturation.

Conditions

Device Performance; Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• SP02 accuracy

  It is required that the Accuracy Root Mean Square (ARMS) performance of the Sponsor's DUT will meet a specification of 3.0 % or better in non-motion conditions for the range of 70 - 100% SaO2 thereby demonstrating an acceptable SpO2 accuracy performance specification. Reference CO-Oximetry will be used as the basis for comparison for the investigational device SpO2 readings.

  April 2026-May 2026

Study Arms (1)

all.health wristband

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 all.health wristband will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Simultaneous data collection will be set up for the device under test and control oximeter.

Device: No intervention (observational study)

Interventions

No intervention (observational study) DEVICE

No intervention

all.health wristband

Eligibility Criteria

• Age: 22 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This study will include a minimum of 24 healthy volunteers.

You may qualify if:

• Participant must have the ability to understand and provide written informed consent.
• Participant is adult 22-50 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 has a resting SpO2 \< 92% as assessed by a pulse oximeter
• 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
• Females who are trying to get pregnant with confirmation of positive urine pregnancy test
• 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)

Sponsors & Collaborators

• All Health, Inc.: lead

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Laurin Priddy

CONTACT

18888975755; researchstudy@all.health

Study Design

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

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): May 11, 2026
• Study Completion (Estimated): May 4, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)