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New finger clip could replace needles for sepsis monitoring

NCT ID NCT04796285

Diagnosis Sponsor: Brigham and Women's Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests a finger-clasp device called Lab Clasp that measures lactate from fluid just under the skin, similar to a pulse oximeter. Researchers want to see if it matches standard blood tests in 6 healthy adults. If it works, it could make sepsis monitoring easier and less invasive.

What this could mean

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

Active substance
Lab Clasp device (finger-based interstitial fluid lactate monitor)
What this could lead to
If successful, this device could allow quick, needle-free lactate monitoring for sepsis, reducing the need for blood draws.
What could go wrong
This is a very small early validation study with only 6 healthy volunteers, so results may not apply to sick patients or real-world settings.

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

6 people

The number who actually took part.

Started

Aug 2022

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 years and older

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. Are 18 years or older 2. In general good health, evidenced by no unstable medical problems (no medication changes in the past 3 months) 3. Have no known skin allergy to the components of the Lab Clasp 4. Willing to comply with all study procedures including providing venous blood samples at the CCI 5. Are English speaking 6. Provide consent to participate in the study Exclusion Criteria: 1. Individuals \<18 years old 2. General frailty of health 3. Prohibitively poor vascular access 4. History of malignancy or active malignancy 5. History of cardiac illness 6. History of HIV on antiretrovirals 7. History of alcohol abuse 8. History of uncontrolled psychiatric illness 9. Recent hospitalization within the past 30 days 10. History of vaping, propylene glycol use 11. History of statin use 12. Non-English speaking 13. Pregnant women, children, vulnerable populations 14. Investigator discretion for suspicion of poor study compliance

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease with sepsis Hyperlactatemia infectious disease infectious disease with sepsis Sepsis

As listed by the trial registrant

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

Infectious disease Lactate blood increase Sepsis Sepsis bacterial

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.