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A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor
NCT04796285 · View on ClinicalTrials.gov ↗
Study 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 onboar
Conditions Studied
Interventions
- DEVICE Lab Clasp
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2026-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04796285
The ClinicalTrials.gov registry entry for NCT04796285 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 929 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention — of which Lab Clasp is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04796285 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04796285 about?
NCT04796285 is a clinical study titled "A Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor". 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 for...
What is the current status of trial NCT04796285?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 6 participants. The study started on 2022-08-01. Estimated completion is 2026-08.
What conditions does trial NCT04796285 study?
This clinical trial studies the following conditions: Sepsis, Infectious Disease, Lactate Blood Increase, Sepsis Bacterial. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04796285?
The interventions under investigation include: Lab Clasp (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04796285?
This trial is sponsored by Brigham and Women's Hospital, which has 929 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04796285 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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