A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
Primary Purpose
Sepsis, Sepsis Bacterial, Lactate Blood Increase
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lab Clasp
Sponsored by
About this trial
This is an interventional diagnostic trial for Sepsis focused on measuring point of care, sepsis, interstitial fluid, lactate
Eligibility Criteria
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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lab Clasp
Arm Description
A finger based device to assay interstitial fluid lactate
Outcomes
Primary Outcome Measures
Comparison of average difference lactate readings between Lab Clasp and laboratory reference values.
The primary outcome measure will be the average difference in lactate values between the Lab Clasp device and the reference (laboratory venous lactate) in healthy volunteers. We will obtain multiple (nine timepoints in total) investigational-reference measurement pairs in each subject (150 minutes total) and will average the difference over all pairs from all subjects.
Secondary Outcome Measures
Measurement of participant experience
We will give each participant a questionnaire when they finish their visit and will ask for their experience (Likert-type scale, 1-5)
Full Information
NCT ID
NCT04796285
First Posted
February 26, 2021
Last Updated
July 25, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
Cambridge Medical Technologies, LLC
1. Study Identification
Unique Protocol Identification Number
NCT04796285
Brief Title
A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
Official Title
A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Cambridge Medical Technologies, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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 performance in reading interstitial fluid lactate values against a known clinical standard in the form of venous lactate levels.
Serum lactate measurements are used clinically as a measure of end-organ dysfunction and physiologic stress. Changes in lactate may indicate worsening infection in the setting of sepsis, drug toxicity for certain xenobiotics, or exercise tolerance in exercise physiology. Serum lactate cutoffs have been developed for various disease states and trigger a variety of medical decisions directed at managing the course of the disease.
A common theme in the application of lactate measurements to understanding changes in physiology is the need to obtain venous blood to determine lactate. While point-of-care assays have been developed that improve the processing speed, there continues to be a need to obtain fingerstick blood or in most cases, venous blood. Obtaining venous blood for serum lactate requires an individual with phlebotomy skills, the processing capabilities of a laboratory to determine lactate concentrations, or the availability of point of care technology.
An alternative method to measure lactate is to sample interstitial fluid which surrounds cells and tissues in the body. Obtaining interstitial fluid is potentially less invasive without the need for repeat phlebotomy or the presence of an indwelling intravenous catheter which can become complicated by infection. The analysis of interstitial fluid for glucose has been validated and is clinically utilized in continuous glucose monitors in individuals with diabetes. In this investigation, the investigators will utilize a novel device, the Lab Clasp to obtain interstitial fluid in a noninvasive method. The Lab Clasp is manufactured to resemble a finger pulse oximeter with additional onboard microfluidics channels that obtain a lactate concentration from interstitial fluid. This streamlined process of obtaining the point of care lactate measurements on demand allows for tasks like serial lactate measurements to be accomplished on a reliable schedule with less workload for nursing staff typically required to draw venous blood. Additionally, the portable and noninvasive nature of the Lab Clasp system may render it usable in facilities that lack skilled staff necessary to perform phlebotomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Sepsis Bacterial, Lactate Blood Increase, Infectious Disease
Keywords
point of care, sepsis, interstitial fluid, lactate
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lab Clasp
Arm Type
Experimental
Arm Description
A finger based device to assay interstitial fluid lactate
Intervention Type
Device
Intervention Name(s)
Lab Clasp
Intervention Description
Finger-based interstitial fluid assessment device
Primary Outcome Measure Information:
Title
Comparison of average difference lactate readings between Lab Clasp and laboratory reference values.
Description
The primary outcome measure will be the average difference in lactate values between the Lab Clasp device and the reference (laboratory venous lactate) in healthy volunteers. We will obtain multiple (nine timepoints in total) investigational-reference measurement pairs in each subject (150 minutes total) and will average the difference over all pairs from all subjects.
Time Frame
150 minutes
Secondary Outcome Measure Information:
Title
Measurement of participant experience
Description
We will give each participant a questionnaire when they finish their visit and will ask for their experience (Likert-type scale, 1-5)
Time Frame
150 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guruprasad Jambaulikar, MBBS, MPH
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
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