LabClasp Wearable Device for Monitoring in Healthy Individuals
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Overseen ByMadeline S Reid
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
The purpose of this study is to validate the LabClasp's ability to estimate blood \[lactate\].
Research Team
Virend Somers, MD, PhD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for healthy adults over 18 who can do high-intensity exercise, are not smokers, haven't been hospitalized recently, aren't in the ICU but have sepsis risk factors. They must be able to consent and agree to regular blood tests for lactate levels.Inclusion Criteria
Aim 2: Nonsmokers
Aim 2: Current ICU patient
Aim 1: Nonsmokers
See 6 more
Exclusion Criteria
Smokers
I am HIV positive and on antiretroviral treatment.
I have or had another type of cancer.
See 1 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants undergo blood lactate measurement using the LabClasp device during clinical assessments or exercise stress tests
1 day
Follow-up
Participants are monitored for safety and effectiveness after treatment
1-2 weeks
Treatment Details
Interventions
- LabClasp
Trial Overview The study is testing LabClasp's technology to estimate blood lactate levels non-invasively during high-intensity exercise compared with traditional blood sampling methods.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Whole-body exercise in healthy adults (Aim 1)Experimental Treatment1 Intervention
Subjects will have blood \[lactate\] measurement obtained with the LabClasp device while completing an exercise stress test on a treadmill or bicycle.
Group II: ICU patients susceptible to developing sepsis (Aim 2)Experimental Treatment1 Intervention
Subjects will have blood \[lactate\] measurement obtained with the LabClasp device as frequently as required for clinical purposes
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Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Trials
3,427
Recruited
3,221,000+
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