Device PerformanceNCT07527000
SpO2 Validation Study - All.Health Algo Oximeter Software
An observational study of Device Performance and Healthy Adult Volunteers, run by All Health, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Device Performance, Healthy Adult Volunteers
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to 7 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include a minimum of 24 healthy volunteers.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 54Show fewer
- 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)
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- implantable active medical device such as pacemaker or automatic defibrillator
- Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent symptomatic head injury (within the last 2 months),
- Cancer requiring chemotherapy, radiation, or current treatment.
- Participants with known clotting disorders (self-reported)
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- current use of blood thinner: prescription or daily use of aspirin
- Sickle Cell Trait or Disease
- Participants with severe contact allergies to standard adhesives, latex, silicone or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- Participants with severe allergies to iodine (only applicable if iodine is used)
- Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g.
- Novocaine),
- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio <0.4)
- Unwillingness or inability to remove nail polish or artificial nails from test digits.
- Surgical hardware in pathway of Device Under Test
- Other known health conditions should be considered upon disclosure in health assessment form.
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
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.
Read the detailed description
The purpose of this clinical study is to validate the SpO2 accuracy performance of the all.health SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the all.health pulse oximeter.
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. An investigational device will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Additional devices may be placed on the back of the wrist with the arterial catheter using a wrist strap. The site(s) where sensors are placed will be measured. Simultaneous data collection will be set up for the device under test and control oximeter.
- Conditions
- Device Performance, Healthy Adult Volunteers
- Being tested
- No intervention (observational study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Device
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2026-May 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start27 Apr 2026
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- All Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527000
- Sponsor's protocol ID
- PR 2025-665
- Status last verified
- May 2026
- First submitted
- 8 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD, observational study
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Validation Study - All.Health Algo Oximeter Software
- ClinicalTrials.gov ID
- NCT07527000
- Acronym / sponsor ID
- PR 2025-665
- Conditions
- Device Performance, Healthy Adult Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- All Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this clinical study is to validate the SpO2 accuracy performance of the all.health SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the all.health pulse oximeter.
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. An investigational device will be placed on the wrist of the side opposite the arterial catheter following the instructions for use. Additional devices may be placed on the back of the wrist with the arterial catheter using a wrist strap. The site(s) where sensors are placed will be measured. Simultaneous data collection will be set up for the device under test and control oximeter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all.health wristband | – | Device: No intervention (observational study)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. |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include a minimum of 24 healthy volunteers.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (54 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No intervention | Device | all.health wristband |
Primary outcome
SP02 accuracy
Time frame: April 2026-May 2026
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. No plan to share IPD, observational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device Performance and Healthy Adult Volunteers, run by All Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 54 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SP02 accuracy (time frame: April 2026-May 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.