Estimating Blood [Lactate] Non-Invasively

NCT05036122 | Withdrawn FDA Device

• 1 other identifier: 21-000318
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate the LabClasp's ability to estimate blood \[lactate\].

Conditions

Healthy

Keywords

High intensity exercise; Stress Testing

Outcome Measures

Primary Outcomes (2)

• Blood [lactate] during incremental exercise

  Measured via venous blood and the LabClasp

  1 day

• Blood [lactate] measurements in ICU patients

  Measured via venous blood and the LabClasp

  1 day

Study Arms (2)

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.

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

Device: LabClasp

Interventions

LabClasp DEVICE

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.

ICU patients susceptible to developing sepsis (Aim 2); Whole-body exercise in healthy adults (Aim 1)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• History of, or active malignancy.
• History of HIV with antiretroviral treatment.
• Smokers.
• Pregnancy.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

• Virend Somers

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (1)