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Can a new pulse oximeter see through melanin to save more lives?

NCT ID NCT07799454

Diagnosis Sponsor: University of North Carolina, Chapel Hill Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers at the University of North Carolina are testing a new pulse oximeter, called MABOS, that uses multiple wavelengths of light to estimate blood oxygen levels. Standard pulse oximeters can be less accurate on darker skin, which may lead to missed low oxygen levels in critically ill patients. This study will enroll up to 120 adults in intensive care who need frequent blood oxygen checks. Participants will wear the MABOS device on their fingers and wrists while the team compares its readings to the gold standard arterial blood gas measurements.

What this could mean

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

Active substance
MABOS, a custom pulse oximeter that uses multiple wavelengths of light to estimate blood oxygen levels
What this could lead to
If it works, this device could give more accurate blood oxygen readings for people with darker skin, reducing missed or delayed treatment in critical care.
What could go wrong
This is an early accuracy study in 120 ICU patients, not a proof that the device improves outcomes. The device may still fail to perform consistently across all skin tones.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

Jan 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Age ranges from 18 to 85 years. * Individuals admitted to one of UNC Hospital's intensive care units (Medical Intensive Care Unit or Cardiovascular and Thoracic Intensive Care Unit). * Individuals with a medical condition necessitating a minimum of two arterial blood gas measurements within a 24-hour period. * Participant, or Legally Authorized Representative (LAR) must be able to read, write, and speak English fluently. Exclusion Criteria: * History of active (clinically significant) skin disorders that make skin vulnerable to contact with conventional electronic devices. * History of allergic response to silicones, adhesives (such as 3M Tegaderm), or acetone. * Broken, damaged or irritated skin or rashes near the sensor application sites. * Presence of tattoos on the fingers, hands, or forearms. * History of a genetic condition or skin disorder that variably impacts the amount of melanin pigmentation (e.g., Vitiligo). * Pregnant or lactating individuals * Individuals given methylene blue within the last 24 hours or Hydroxocobalamin within the last 2 weeks. * Individuals experiencing carbon monoxide poisoning. * History of conditions that may affect ABG readings (e.g., lipemic specimens). * History of hematological conditions affecting red blood cell morphology (e.g., sickle cell disease) * Patients on Venoarterial extracorporeal membrane oxygenation (VA-ECMO), durable left ventricular assist device (LVAD), or Impella.

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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.

Hypoxemia

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of North Carolina at Chapel Hill Hospitals

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

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