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New device aims to measure blood oxygen without needles

NCT ID NCT07503171

Knowledge-focused Sponsor: Nihon Kohden Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a new noninvasive device that measures oxygen and hemoglobin levels in 7 healthy adults. Participants will be exposed to controlled low oxygen and blood dilution to see how well the device works compared to standard blood tests. The goal is to improve monitoring technology for future patient care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Noninvasive Physiological Monitoring Device (Octopal R DMO-8000X with TL 811S Finger Probe)
What this could lead to
If successful, this could lead to better noninvasive monitors for oxygen and hemoglobin levels, improving patient care in hospitals.
What could go wrong
This is a very small, early-stage study with only 7 healthy volunteers. Results may not apply to sick patients, and the device may not perform as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 7 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy adult volunteers. At least 7 subjects will be enrolled. Subjects will be selected with reference to ISO and FDA requirements to ensure appropriate representation across skin tone categories (Monk Skin Tone scale) and sex.

Ages

18 to 35 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. In good general health with no evidence of significant medical problems. 2. Fluent in both written and spoken English. 4\. Has provided written informed consent and is willing to comply with study procedures. Exclusion Criteria: 1. BMI above 30. 2. History of heart, lung, kidney, or liver disease. 3. Diagnosis of asthma, sleep apnea, or use of CPAP. 4. Diabetes mellitus. 5. Clotting disorders. 6. Hemoglobinopathy or history of anemia (ctHb \<12 g/dL for men, \<11 g/dL for women, COHb \>2%). 7. Any serious systemic illness. 8. Current smoker. 9. Injury or abnormality at sensor sites interfering with measurements. 10. History of fainting or vasovagal response. 11. Sensitivity to local anesthesia. 12. Diagnosis of Raynaud's disease. 13. Unacceptable collateral circulation (Allen's test). 14. Pregnant, lactating, or attempting to become pregnant. 15. Unable or unwilling to provide informed consent or comply with study procedures. 16. Any other condition deemed unsuitable by the investigator.

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemodilution Hypoxia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vital Sign Research Group

    San Francisco, California, 94107, United States

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