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Lab Clasp Device for Sepsis Monitoring
N/A
Waitlist Available
Led By Guruprasad Jambaulikar, MBBS, MPH
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are English speaking
Are 18 years or older
Must not have
Non-English speaking
History of malignancy or active malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 150 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to compare the accuracy of the Lab Clasp in measuring interstitial fluid lactate to that of venous lactate levels.
Who is the study for?
This trial is for English-speaking adults over 18 in good health, without recent medication changes or unstable medical issues. Participants must not have skin allergies to Lab Clasp materials, a history of serious illness like cancer or heart disease, poor veins for drawing blood, recent hospital stays, substance abuse problems, or be on certain medications like statins.
What is being tested?
The study tests the Lab Clasp device's ability to monitor sepsis risk by measuring lactate levels in interstitial fluid and comparing these readings with traditional venous blood samples. The goal is to validate this noninvasive method against the current clinical standard.
What are the potential side effects?
Since the Lab Clasp is a noninvasive monitoring device similar to a pulse oximeter used on fingers, side effects are minimal but may include potential skin irritation at the site of application if an allergy exists.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I speak English.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
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I have had cancer before or have it now.
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I am under 18 years old.
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I have a history of heart problems.
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I am HIV positive and on antiretroviral therapy.
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I am not pregnant, a child, or part of a vulnerable population.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 150 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~150 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Comparison of average difference lactate readings between Lab Clasp and laboratory reference values.
Secondary study objectives
Measurement of participant experience
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lab ClaspExperimental Treatment1 Intervention
A finger based device to assay interstitial fluid lactate
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,843,460 Total Patients Enrolled
Cambridge Medical Technologies, LLCIndustry Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Guruprasad Jambaulikar, MBBS, MPHPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used vaping or propylene glycol in the past.You are generally in poor health and not physically strong.I do not speak English.You have very difficult or impossible access to your blood vessels.You have a history of drinking too much alcohol.I speak English.I am 18 years old or older.I have had cancer before or have it now.I am under 18 years old.I have a history of heart problems.I am HIV positive and on antiretroviral therapy.I am not pregnant, a child, or part of a vulnerable population.I have taken statins before.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.