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NCT05036122 Clinical Trial

Estimating Blood [Lactate] Non-Invasively

Healthy Clinical Trial

Official title:
Validation of a Non-Invasive Instrument to Estimate Blood Lactate

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05036122
Other study ID # 21-000318
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2025
Est. completion date December 2025

Study information
Verified date March 2024
Source Mayo Clinic
Contact Madeline S Reid
Phone 507-255-0007
Email Reid.Madeline@mayo.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date December 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - Aim 1: - 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. Inclusion Criteria - Aim 2: - 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. Exclusion Criteria - Aims 1 and 2: - History of, or active malignancy. - History of HIV with antiretroviral treatment. - Smokers. - Pregnancy.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LabClasp
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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood [lactate] during incremental exercise Measured via venous blood and the LabClasp 1 day
Primary Blood [lactate] measurements in ICU patients Measured via venous blood and the LabClasp 1 day
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