HealthyNCT06947447
WatchPAT SpO2 Validation Study
An observational study of Healthy, run by Itamar-Medical, Israel at 1 site in United States.
Trial summary
Validate the SpO2 accuracy of the WatchPAT compared to arterial blood CO-Oximetry Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 2 May 2025
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 24 healthy male and female participants of any race, ranging in pigmentation from light to dark, aged 18-50 years old
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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 colored nail polish or non-clear 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
Validate the SpO2 accuracy of the WatchPAT compared to arterial blood CO-Oximetry
Read the detailed description
The goal of this comparative, single-center, non-randomized study is to validate the SpO2 accuracy performance of the WatchPAT SpO2 sensor over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry in 24 healthy male and female participants of any race, ranging in pigmentation from light to dark, aged 18-50 years old. 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, while an investigational device will be placed on the fingers of both hands.
- Conditions
- Healthy
- Being tested
- No intervention
- Keywords
- Arterial Oxygen Saturation, Oxygen Saturation, WatchPAT, SpO2 sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDevice
Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy
WatchPAT SpO2 accuracy performance over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
Measured: April-May 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start21 Apr 2025
- Primary completion2 May 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Itamar-Medical, Israel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Element Materials Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947447
- Sponsor's protocol ID
- PR# 2024-598
- Status last verified
- Aug 2025
- First submitted
- 20 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WatchPAT SpO2 Validation Study
- ClinicalTrials.gov ID
- NCT06947447
- Acronym / sponsor ID
- PR# 2024-598
- Conditions
- Healthy
- Keywords
- Arterial Oxygen Saturation, Oxygen Saturation, WatchPAT, SpO2 sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Itamar-Medical, IsraelIndustry (pharma, biotech, devices)
- Collaborators
- Element Materials Technology
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 27 Apr 2025 (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.
Validate the SpO2 accuracy of the WatchPAT compared to arterial blood CO-Oximetry
Detailed description
The goal of this comparative, single-center, non-randomized study is to validate the SpO2 accuracy performance of the WatchPAT SpO2 sensor over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry in 24 healthy male and female participants of any race, ranging in pigmentation from light to dark, aged 18-50 years old. 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, while an investigational device will be placed on the fingers of both hands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WatchPAT SpO2 | – | Device: No interventionSimultaneous 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 24 healthy male and female participants of any race, ranging in pigmentation from light to dark, aged 18-50 years old
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (51 listed)
- 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)
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 interventionDevice | Device | WatchPAT SpO2 |
Primary outcome
SpO2 Accuracy
Time frame: April-May 2025
WatchPAT SpO2 accuracy performance over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
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 22 Aug 2025.
- Individual participant dataSharing planned: No
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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 Healthy, run by Itamar-Medical, Israel 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 51 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 22 Aug 2025. 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?
SpO2 Accuracy (time frame: April-May 2025). 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 22 Aug 2025.