HealthyNCT05036122
Estimating Blood [Lactate] Non-Invasively
A study testing LabClasp in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to validate the LabClasp's ability to estimate blood [lactate]. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LabClasp
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be able to provide written consent.
- Adults 18 years of age and older.
- Nonsmokers.
- No recent hospitalization (< 60 days).
- Ability to perform high-intensity exercise.
- Subjects must be able to provide written consent to be included in the research study.
Show all 11Show fewer
- Adults 18 years of age and older.
- Nonsmokers.
- Current ICU patient.
- Have regular blood samples taken for [lactate] measurements.
- Have one or more risk factors for sepsis.
Who cannot join
- History of, or active malignancy.
- History of HIV with antiretroviral treatment.
- Smokers.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Validation of a Non-Invasive Instrument to Estimate Blood Lactate
The purpose of this study is to validate the LabClasp's ability to estimate blood [lactate].
- Conditions
- Healthy
- Being tested
- LabClasp
- Keywords
- High intensity exercise, Stress Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabClaspDevice
Non-invasive device that estimates blood [lactate] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood [lactate] and return a value to the subject via an accompanying tablet within 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body exercise in healthy adults (Aim 1) | Experimental | Subjects will have blood [lactate] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle. Receives: Device: LabClasp |
| ICU patients susceptible to developing sepsis (Aim 2) | Experimental | Subjects will have blood [lactate] measurement obtained with the LabClasp device as frequently as required for clinical purposes Receives: Device: LabClasp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood [lactate] during incremental exercise
Measured via venous blood and the LabClasp
Measured: 1 day
Blood [lactate] measurements in ICU patients
Measured via venous blood and the LabClasp
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study startJan 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The sensors needed for the study were not available
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.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virend Somers, MD, PhD, Mayo Clinic
- Investigators
- Virend Somers, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036122
- Sponsor's protocol ID
- 21-000318
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Non-Invasive Instrument to Estimate Blood Lactate
- ClinicalTrials.gov ID
- NCT05036122
- Acronym / sponsor ID
- 21-000318
- Conditions
- Healthy
- Keywords
- High intensity exercise, Stress Testing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The sensors needed for the study were not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Sep 2021 (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 purpose of this study is to validate the LabClasp's ability to estimate blood [lactate].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole-body exercise in healthy adults (Aim 1) | Experimental | Device: LabClaspSubjects will have blood [lactate] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle. |
| ICU patients susceptible to developing sepsis (Aim 2) | Experimental | Device: LabClaspSubjects will have blood [lactate] measurement obtained with the LabClasp device as frequently as required for clinical purposes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must be able to provide written consent.
- Adults 18 years of age and older.
- Nonsmokers.
- No recent hospitalization (< 60 days).
- Ability to perform high-intensity exercise.
Key exclusion criteria (4 listed)
- History of, or active malignancy.
- History of HIV with antiretroviral treatment.
- Smokers.
- Pregnancy.
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 |
|---|---|---|
| LabClaspNon-invasive device that estimates blood [lactate] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood [lactate] and return a value to the subject via an accompanying tablet within 20 seconds. | Device | ICU patients susceptible to developing sepsis (Aim 2), Whole-body exercise in healthy adults (Aim 1) |
Primary outcome
Blood [lactate] during incremental exercise
Time frame: 1 day
Measured via venous blood and the LabClasp
Blood [lactate] measurements in ICU patients
Time frame: 1 day
Measured via venous blood and the LabClasp
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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.
Virend Somers principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LabClasp in people with Healthy, run by Mayo Clinic 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 11 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Mar 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 was withdrawn before enrolling participants, so there are no results.
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?
Blood [lactate] during incremental exercise (time frame: 1 day). The study lists 2 primary outcomes in all. 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 Mar 2026.