Clinical trials: Point-of-Care Systems
HIV 1 Infection, HIV 2 Infection
A Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test
The objectives of this study are as follows: To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care…
- Conditions
- HIV 1 Infection, HIV 2 Infection, Syphilis Infection, Hepatitis B Infection
- Trial name
- NCT07563309
- Testing
- TruPlex HIV/HepB/Syphilis Rapid Test
- Where
- 3 sites in South Africa
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Combined Point of Care Diagnostic of HIV, HBV and HCV
Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV…
- Trial name
- MAGICIEN (NCT06082336)
- Testing
- MagIA IBC test in capillary blood, MagIA IBC test in other blood matrices
- Where
- 2 sites in France
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- MagIA Diagnostics
Anticoagulant Therapy
Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation.
- Trial name
- PHAPOCU (NCT05491460)
- Testing
- Apixaban 5 MG Tab, Dabigatran 150 MG Tab, Edoxaban 60Mg Tab
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Doasense GmbH
Influenza Human
Clinical Validation of the Point-of-Care MSD Influenza Test
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT00863343
- Testing
- Public Health Notification
- Where
- 3 sites in United States
- Volunteers
- 391 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Influenza Type A, Influenza Type B
Influenza A+B Test Kit Performance Study
Prospective clinical study on the performance of an Influenza A+B rapid test kit. The main goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to a gold standard.
- Trial name
- NCT03895268
- Testing
- ALiA Analyser, Influenza A+B Test Kit
- Where
- Hong Kong
- Volunteers
- 600 people
- Sponsor
- Sanwa BioTech Limited
SARS-CoV-2 Infection, Influenza A
SARS-CoV-2 and Influenza A/B in Point-of-Care and Non-Laboratory Settings
The Metrix COVID/Flu Test will be evaluated for use in Point-of-Care and Non-Laboratory settings in a home testing environment utilizing the clinical study design described herein.
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B
- Trial name
- NCT06191393
- Testing
- Aptitude Medical Systems Metrix COVID/Flu Test
- Where
- 3 sites in United States
- Volunteers
- 614 people
- Sponsor
- Aptitude Medical Systems
Brain Injuries
Validation Of TBI Detection System For Head Injured Patients
A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.
- Trial name
- B-AHEAD III (NCT02367300)
- Testing
- BrainScope Ahead 200
- Where
- 11 sites in United States
- Volunteers
- 981 people
- Sponsor
- BrainScope Company, Inc.
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
Asthma
Use of fenoTRACK Device for Monitoring Changes of Fractional Exhaled Nitric Oxide (FeNO) in Uncontrolled Asthma Subjects and Controlled Asthma Subjects
This study incorporates objectives directed at two subject cohorts: 1. Uncontrolled Adult and Pediatric Asthma Subjects: To demonstrate a statistically significant and clinically meaningful decline in Point Of Care (POC) FeNO as…
- Trial name
- NCT07228026
- Testing
- fenoTRACK Device
- Where
- 13 sites in United States
- Volunteers
- 160 people
- Sponsor
- Biometry Inc
Antenatal Care, Maternal Health
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
FS2 evaluates the diagnostic accuracy and implementation feasibility of an AI-assisted blind-sweep obstetric ultrasound (SPAQ E-con AI), operated by trained non-specialist health workers, for antenatal screening in rural…
- Conditions
- Antenatal Care, Maternal Health, Gestational Age, Placenta Praevia
- Trial name
- FS2 (NCT07677670)
- Testing
- SPAQ E-con AI blind-sweep ultrasound
- Where
- Democratic Republic of the Congo
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- SOIK Corporation Sarl
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® Esterase for Screening Wound Infection at Point of Care
This non-interventional, single-blinded, prospective, observational study assesses the planar distribution of leukocyte esterase in wounds by placing wound exudates soaked wound dressings in the DETEC® Esterase device during…
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer
- Trial name
- NCT04614870
- Testing
- DETEC® Esterase
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Progenitec Inc.
Ischemic Stroke, Ischemia
Biomarkers of Acute Stroke in Clinic
The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below: Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic…
- Conditions
- Ischemic Stroke, Ischemia, Atrial Fibrillation, Transient Ischemic Attack
- Trial name
- BASIC (NCT03897478)
- Testing
- ISCDX blood test
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Ischemia Care LLC
Acute Coronary Syndrome, Myocardial Infarction
RAMP 200 / RAMP Cardiovascular Tests at the Point-of-Care
This clinical investigation is designed to demonstrate the performance characteristics of the RAMP® cardiac tests analyzed on the RAMP® 200 by non-laboratorial Operators at the point-of-care when compared to the results for the…
- Conditions
- Acute Coronary Syndrome, Myocardial Infarction, Heart Failure, Congestive Heart Failure
- Trial name
- C-POC (NCT02191735)
- Testing
- RAMP 200, RAMP Reader
- Where
- 3 sites in United States
- Volunteers
- 719 people
- Sponsor
- Response Biomedical Corp.
Covid19, COVID-19 Pneumonia
imPulse™ Una Infrasound-to-ultrasound E-stethoscope
This study generates robust, uniform clinical data across emerging COVID-19 strains to train ML/AI algorithms of the Sponsor's imPulse™ Una infrasound-to-ultrasound e-stethoscope for digital diagnostic feature synthesis of…
- Conditions
- Covid19, COVID-19 Pneumonia, COVID-19 Respiratory Infection, COVID-19 Acute Respiratory Distress Syndrome
- Trial name
- NCT04941209
- Testing
- imPulse™ Una infrasound-to-ultrasound e-stethoscope, (PPA >95%) FDA EUA RT-PCR, HR-CT-scan
- Where
- 3 sites in Democratic Republic of the Congo, India and 1 more
- Volunteers
- 702 people
- Sponsor
- Level 42 AI, Inc.
COVID-19, Asymptomatic COVID-19
A Clinical Evaluation of Proof Diagnostics Test System Including the Proof Diagnostics Reader and COVID-19 Test
To determine the accuracy of Proof Diagnostics COVID-19 Test in the intended, symptomatic and suspected/at-risk asymptomatic population and point-of-care use as compared to a standard molecular comparator, Quidel Lyra SARS-CoV-2…
- Trial name
- NCT05331976
- Testing
- Proof Lab Test System
- Where
- 3 sites in United States
- Volunteers
- 276 people
- Sponsor
- Proof Diagnostics
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
Type 2 Diabetes Mellitus
A 6-month Clinical Study to Evaluate the Effect of a Digital Disease Management Tool in Patients With T2DM
Type 2 diabetes mellitus is a complex, chronic disease that requires a comprehensive treatment plan aimed at meeting multitude therapeutic targets associated with micro- and macro-vascular risk reduction.
- Trial name
- NCT03090464
- Testing
- Use of digital disease management tool
- Where
- 46 sites in United States
- Volunteers
- 328 people
- Sponsor
- AstraZeneca
Upper Respiratory Infections
Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's instructions by personnel in laboratories…
- Trial name
- NCT02232711
- Where
- 4 sites in United States
- Volunteers
- 1,082 people
- Sponsor
- BioFire Diagnostics, LLC
Diabetes Mellitus, Type 2, Overweight
A Study to Evaluate the Effect of Fasting Duration and Tirzepatide Withholding on the Amount of Food and Fluid in the Stomach in Participants With Type 2 Diabetes Mellitus and Participants With Overweight or Obesity Without Type 2 Diabetes Mellitus
The purpose of this study is to evaluate how fasting and stopping the use of tirzepatide affects the amount of food and drink that stays in the stomach after a meal.
- Conditions
- Diabetes Mellitus, Type 2, Overweight, Obesity
- Trial name
- NCT07299084
- Testing
- Tirzepatide
- Where
- Singapore
- Volunteers
- 40 people
- Sponsor
- Eli Lilly and Company
Pressure Ulcer
Comparative Prevention-effectiveness Trial of DabirAIR Overlay System
Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative setting.
- Trial name
- NCT02565797
- Testing
- DabirAIR alternating pressure overlay
- Where
- United States
- Volunteers
- 392 people
- Sponsor
- Dabir Surfaces Inc