Clinical trials: Point of Care
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
Viral Conjunctivitis
ADenoVirus Initiative Study in Epidemiology in France
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.
- Trial name
- NCT02054234
- Where
- 19 sites in France
- Volunteers
- 357 people
- Sponsor
- NicOx
Influenza, Human, Respiratory Syncytial Virus Infections
Evaluation of Performance of the LumiraDx Influenza A/B + RSV Test at POC Testing Sites
A Multicenter Study Conducted to Evaluate the Performance of the LumiraDx Influenza A/B + RSV Test at Point of Care Testing Sites
- Trial name
- INSPIRE (NCT04288921)
- Testing
- Swab
- Where
- 20 sites in United States
- Volunteers
- 525 people
- Sponsor
- LumiraDx UK Limited
Syphilis, Syphilis Infection
Retrospective Study of iStatis Syphilis Ab Test (POC)
The purpose of this retrospective clinical trial is to establish the clinical performance of the iStatis Syphilis AbTest. The data will be used to demonstrate the product is safe and effective for its intended use.
- Trial name
- NCT06367621
- Testing
- iStatis Syphilis Antibody Test
- Where
- South Africa
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Diabetes Mellitus, Type 2, Liver Diseases
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
- Conditions
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases
- Trial name
- RESPYR-SBA (NCT07646015)
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Respyr
COVID-19
Performance Evaluation of LumiraDx COVID-19 (SARS-CoV-2) Ag ULTRA Test
Performance of the LumiraDx SARS-CoV-2 Ag ULTRA assay will be assessed by comparison to a reference method
- Trial name
- ASPIRE-2 (NCT05506618)
- Testing
- Nasal Swab, Nasopharyngeal swab
- Where
- 6 sites in United States
- Volunteers
- 758 people, healthy volunteers welcome
- Sponsor
- LumiraDx UK Limited
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
HCV Infection
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
A multicenter prospective study to evaluate the clinical performance, usability, and contrived result interpretation of the INSTI® HCV Antibody Test (INSTI HCV) with fingerstick (FS) whole blood specimens from participants with…
- Trial name
- NCT07904403
- Testing
- INSTI HCV Antibody Test
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
Cardiac Disease
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit
This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit.
- Trial name
- NCT04203251
- Testing
- Caption Health Guidance Technology
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Caption Health, Inc.
Gonorrhea Infection
A Study to Evaluate the Performance, Usability, and Contrived Result Interpretation of iStatis Gonorrhea Antigen Test
The objective of this study is to evaluate the performance, usability, and contrived result interpretation of iStatis Gonorrhea Antigen Test (iStatis Gonorrhea Test) in the intended near-patient or point-of-care setting by…
- Trial name
- NCT07569900
- Testing
- iStatis Gonorrhea Antigen Test
- Where
- 3 sites in South Africa
- Volunteers
- 650 people, healthy volunteers welcome
- Sponsor
- bioLytical Laboratories
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.
Anticoagulant Therapy
In Vitro Diagnostic Test for DOAC in Urine
This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants…
- Trial name
- PADOASU (NCT03182829)
- Testing
- DOAC Dipstick
- Where
- 18 sites in Germany
- Volunteers
- 880 people
- Sponsor
- Doasense GmbH
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.
Breast Cancer
A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined…
- Trial name
- NCT02888366
- Where
- 4 sites in United States
- Volunteers
- 500 people
- Sponsor
- Menssana Research, Inc.
Coagulation
Reference Range Analysis of the Entegrion Point of Care Coagulation Monitor (PCM™) in Healthy Volunteers
This study is intended to define the PCM normal laboratory range.
- Trial name
- NCT03133351
- Testing
- PCM
- Where
- 2 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Entegrion, Inc.
Coronary Artery Disease
Non-invasive Point-of-care Diagnosis Using Machine Learning and Signal Analytics to Transform Early Detection of Heart Disease
This study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the Phase Signal Recorder (PSR) prior to coronary angiography.
- Trial name
- IDENTIFY (NCT03864081)
- Testing
- Phase Signal Recorder
- Where
- United States
- Volunteers
- 2,500 people
- Sponsor
- Analytics For Life
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
Heart Failure, High Blood Pressure
BVA-200 vs BVA-100 Validation Study
The proposed study is a prospective, observational, investigator and patient blinded study comparing the results of blood volume measurement using the FDA-cleared Daxor BVA-100 device to the Daxor BVA-200 device.
- Conditions
- Heart Failure, High Blood Pressure, High Cholesterol, Anemia
- Trial name
- NCT06227819
- Testing
- BVA-200
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Daxor Corporation
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
COVID-19, COVID
Clinical Validation of the Aptitude Medical Systems Metrix COVID-19 Test
The Metrix COVID 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.
- Trial name
- NCT06744660
- Testing
- Aptitude Medical Systems Metrix COVID Test
- Where
- 3 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Aptitude Medical Systems