Clinical trials: Point-of-Care Systems
Acute Respiratory Infections (ARIs)
FebriDx® Pediatric Validation Study
The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the…
- Trial name
- NCT07211997
- Testing
- FebriDx
- Where
- 10 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics
Sepsis
Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical…
- Trial name
- NCT04529733
- Testing
- IB10 sphingotest PCT+
- Volunteers
- 300 people
- Sponsor
- Nexus DX
SARS-Cov-2, Covid19
Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 (COVID-19) IgG Antibody Test in Fingerstick Whole Blood
Prospective, multi-center, observational, blinded clinical trial to compare a new point of care (POC) SARS-CoV-2 IgG antibody test to a reference SARS-CoV-2 PCR test using fingerstick whole blood.
- Trial name
- NCT04699903
- Testing
- POC SARS-Cov-2 IgG Antibody test
- Where
- 3 sites in United States
- Volunteers
- 201 people
- Sponsor
- Lumos Diagnostics
Hepatitis B, Hepatitis B Infection
A Study to Evaluate Diagnostic Sensitivity and Specificity of iStatis HBsAg Test at the Point-Of-Care Sites
A prospective cross-sectional study in which surgically non-invasive sample-taking is done only for the purpose of the study. Capillary (fingerstick) whole blood and EDTA venipuncture whole blood are collected by a healthcare…
- Trial name
- NCT06368466
- Testing
- iStatis HBsAg Test
- Where
- Australia
- Volunteers
- 175 people
- Sponsor
- bioLytical Laboratories
Sepsis, Sepsis Bacterial
Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.
- Trial name
- NCT05627076
- Testing
- Blood Sampling
- Where
- France
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Abionic SA
Pregnancy Related
Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients…
- Trial name
- NCT03575286
- Testing
- Pregnancy test
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Voyant Diagnostics, Inc.
Congestive Heart Failure
Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
- Trial name
- NCT02107495
- Testing
- Samsung LABGEO IVD-A20 CHF Test
- Where
- 3 sites in United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Samsung Electronics
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
SARS-CoV-2, Influenza A
POC Performance Evaluation of LumiraDx SARS-CoV-2 Ag Ultra and SARS-CoV-2 & Flu A/B Tests.
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 Ag Ultra test in detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and LumiraDx SARS-CoV-2 \& Flu A/B…
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, COVID-19
- Trial name
- PURSUE (NCT05728970)
- Testing
- LumiraDx SARS-CoV-2 Ag Ultra, LumiraDx SARS-CoV-2 & Flu A/B
- Where
- 10 sites in United States
- Volunteers
- 716 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
Salivary Immunity
Salivary Immunoglobulin A (sIgA) Normal Range Study
Salivary Immunoglobulin A (sIgA) is a marker of immune system activity. Typically, sIgA is determined by an ELISA test in which samples have to be sent to a specialized laboratory for testing.
- Trial name
- sIgA (NCT06248788)
- Testing
- PoC Device
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- 4Life Research, LLC
Embolism and Thrombosis, Infection
Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests
A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to Results on the Reference…
- Conditions
- Embolism and Thrombosis, Infection, Inflammation
- Trial name
- NOVEL-3 (NCT04375982)
- Testing
- Venepuncture, Fingerstick
- Where
- 4 sites in United States
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
Hemostasis Monitoring
Comparative Analysis of PCM With ROTEM in the Measurement of Viscoelastic Coagulation Parameters
To determine if PMC viscoelastic coagulation parameters correlate with those generated by a marketed device in adult patients who require hemostasis monitoring or who are at risk of bleeding or thrombotic indications
- Trial name
- NCT03679286
- Testing
- PCM and ROTEM
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Entegrion, Inc.
Hepatic Disease
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.
- Trial name
- NCT02104154
- Testing
- Samsung LABGEO PT10 Hepatic Panel
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Samsung Electronics
Lung Disease, Lung Ultrasound
Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath
This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study.
- Trial name
- NCT07046234
- Testing
- Lung ultrasound
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- GE Healthcare
Acute Respiratory Tract Infections
FebriDx DISRUPT Acute Respiratory Infection Trial in Acute Respiratory Infection: An Evaluation of FebriDx® POC Test
The aim of this study is to determine performance characteristics of the FebriDx test in predicting viral or bacterial infection etiology among febrile (observed or reported) patients presenting the emergency department, urgent…
- Trial name
- NCT02018198
- Testing
- FebriDx
- Where
- 20 sites in United States
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- Rapid Pathogen Screening
Acute Coronary Syndrome
Clinical Study to Validate the Use of a New Point of Care Troponin I Test
This trial is designed as a prospective, multi-center, observational study of "all-comers" eligible adult subjects presenting to participating emergency departments with symptoms suggestive of acute coronary syndrome (ACS)
- Trial name
- NCT02620397
- Where
- 14 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Trinity Biotech
Cardiac Disease
Point-of-Care Echocardiography With Assistance Technology
Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA…
- Trial name
- NCT03897140
- Testing
- Diagnostic Test: Limited Echocardiogram
- Where
- 2 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Sara Guttas
COVID-19
COVID-19: A POC Test Under Research & Evaluation
Collection of nasal/nasopharyngeal/throat swabs and blood samples from patients presenting at their designated care facility displaying symptoms of COVID-19 and undergoing a SOC SARS-CoV-2 test or those who have tested positive…
- Trial name
- CAPTURE (NCT04408066)
- Testing
- Sample Collection/Performance Evaluation (A), Sample Collection/Performance Evaluation (B)
- Where
- 3 sites in United Kingdom
- Volunteers
- 523 people
- Sponsor
- LumiraDx UK Limited
SARS-CoV-2, Covid19
Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)
Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.
- Trial name
- CoviDx (NCT04750629)
- Testing
- POC CoviDx™ Rapid Antigen Test
- Where
- 2 sites in United States
- Volunteers
- 140 people
- Sponsor
- Lumos Diagnostics
Acute Myocardial Infarction
SpinChip Hs-cTnI Sample Type Validation
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-2 (NCT06453707)
- Testing
- SpinChip hs-cTnI
- Where
- Norway
- Volunteers
- 180 people
- Sponsor
- SpinChip Diagnostics ASA