Clinical trials: Point-of-Care Systems
- Condition Point-of-Care Systems
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Syphilis, Treponema Pallidum
A Cross-sectional Investigational Study to Evaluate the Sensitivity, Specificity, and Utility of the MedMira Inc. Multiplo® Complete Syphilis (TP/nTP) Antibody Test (POCT) to Diagnose Infectious Syphilis in Participants Attending the Sexual Health Clinic in Ottawa, Ontario.
Due to the recent resurgence of infectious syphilis in Canada and the changing epidemiology of the disease to involve heterosexuals and females of child bearing age leading to a record number of congenital syphilis cases and…
- Trial name
- NCT06586905
- Testing
- Medical Device
- Where
- Canada
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
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
Acute Myocardial Infarction
Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients.
The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac…
- Trial name
- AMIRST (NCT01536106)
- Testing
- Autologous Bone marrow mononuclear cells
- Where
- 3 sites in India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- TotipotentRX Cell Therapy Pvt. Ltd.
Chlamydia Trachomatis, Gonorrhea
Evaluation of the Atlas Genetics io® CTNG System
Atlas Genetics io® system results are compared with those obtained from comparator devices.
- Trial name
- IO-CTNG (NCT03071510)
- Testing
- Atlas Genetics io® system
- Where
- 10 sites in United States
- Volunteers
- 7,128 people, healthy volunteers welcome
- Sponsor
- Binx Health Limited
Hemolysis, Blood Specimen Collection
Clinical Study of a Novel Hemolysis Point of Care Test at an Emergency Department.
This study aims to investigate the outcome of hemolysis frequency when a hemolysis point of care test is introduced in an emergency department.
- Trial name
- NCT02976610
- Testing
- Hemolysis Point-of-Care test
- Where
- Sweden
- Volunteers
- 1,671 people, healthy volunteers welcome
- Sponsor
- Hemcheck Sweden AB
Age-Related (Dry) Macular Degeneration
Real-World Evaluation of AI Enabled Multi-Spectral Imaging (MSI) for AMD Biomarker Detection
The goal of this observational clinical study is to learn if DeepMSI AI detects age-related macular degeneration (AMD) biomarkers with sensitivity and specificity equivalent to experienced clinicians in adults over 40 years old.
- Trial name
- NCT07446582
- Testing
- Retina imaging device (MSI-120) and AI (DeepMSI AI)
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- AI-Spectral
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
Chronic Kidney Diseases, Kidney Injury, Acute
Clinical Performance of a Point-of-Care Creatinine Testing System in Individuals With Kidney Disease
The goal of this clinical performance study is to evaluate the accuracy and usability of the Eaglenos Creatinine Test System(referred to as EG), a point-of-care testing (POCT) system that consists of a handheld device and its…
- Trial name
- NCT07251075
- Testing
- Reference Creatinine Test System(Cobas c 111), Investigational Creatinine Test System (EG)
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Tingting Xu
Diagnoses Disease
Evaluation of HemoTypeSC as a Novel Rapid Test for Point-of-Care Screening for Sickle-Cell Disease, Hemoglobin C Disease, and Carrier Status in Low-Resource Settings
Sickle cell disease is a life-threatening genetic disorder that can be effectively treated following early diagnosis via newborn screening.
- Trial name
- NCT03619798
- Testing
- HemoTypeSC
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Silver Lake Research Corporation
Gingivitis, Periodontal Disease
Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.
- Trial name
- NCT02403297
- Testing
- Quik Check PD
- Where
- United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Innovative Diagnostics Inc
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
Smoking, Tobacco Use Disorder
QuitAdvisorMD: A Point-of-care Tool for Brief Smoking Cessation Interventions
QuitAdvisorMD: A point-of-care tool for brief smoking cessation interventions Under a Phase II SBIR grant supported by NIH/NIDA, we are developing QUITAdvisorMD: a point-of-care, patient-centered resource for counseling patients…
- Trial name
- NCT01065493
- Testing
- QuitAdvisorMD Software Algorithm, Standard Smoking Cessation Counseling
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Silverchair Science & Communications, 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
Venus Leg Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
- Trial name
- NCT01537003
- Testing
- Promogran, Coban 2 layer
- Where
- 7 sites in United States, Germany and 2 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management
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.
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
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
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
Diabetic Foot Ulcers
WOUNDCHEK™ Protease Status Point of Care (POC) Diagnostic Test on DFU
The purpose of this trial is to determine if wounds with elevated protease activity (EPA) treated with targeted interventions such as protease modulating therapies can improve clinical and economic outcomes.
- Trial name
- NCT01537016
- Testing
- PROMOGRAN, Tielle
- Where
- 5 sites in United States, Germany and 3 more
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Systagenix Wound Management