Status:
UNKNOWN
A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Cambridge Medical Technologies, LLC
Conditions:
Sepsis
Sepsis Bacterial
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall purpose of this study is to demonstrate the usability of a clinical-grade device in the form of a finger clasp similar to a pulse oximeter for monitoring lactate values, by comparing its p...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Are 18 years or older
- In general good health, evidenced by no unstable medical problems (no medication changes in the past 3 months)
- Have no known skin allergy to the components of the Lab Clasp
- Willing to comply with all study procedures including providing venous blood samples at the CCI
- Are English speaking
- Provide consent to participate in the study
- Exclusion Criteria:
- Individuals \<18 years old
- General frailty of health
- Prohibitively poor vascular access
- History of malignancy or active malignancy
- History of cardiac illness
- History of HIV on antiretrovirals
- History of alcohol abuse
- History of uncontrolled psychiatric illness
- Recent hospitalization within the past 30 days
- History of vaping, propylene glycol use
- History of statin use
- Non-English speaking
- Pregnant women, children, vulnerable populations
- Investigator discretion for suspicion of poor study compliance
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04796285
Start Date
August 1 2022
End Date
August 1 2024
Last Update
July 27 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115