Clinical trials: Detection
Caries,Dental
Clinical Trial Proximal Caries Infiltration and Detection
The purpose of this study is to investigate the clinical efficacy of resin infiltration (Icon, DMG, Germany) compared to fluoride varnish (Duraphat Fluoride Varnish, Colgate, USA) in the management of proximal early caries…
- Trial name
- NCT01796106
- Testing
- Resin infiltration, Fluoride varnish & Oral hygiene instruction
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- DMG Dental Material Gesellschaft mbH
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, Inc.
Pneumonia
Detection of Microorganisms and Antibiotic Resistance Genes Using the Curetis Unyvero LRT55 Application
The Curetis Unyvero LRT55 Application is intended to detect and to identify genes of 21 microorganisms and 19 genes associated with antibiotic resistance in 4 hours.
- Trial name
- LRT55 (NCT01922024)
- Testing
- LRT55 Testing
- Where
- 9 sites in United States
- Volunteers
- 2,124 people
- Sponsor
- Curetis GmbH
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
- Trial name
- NCT01298323
- Testing
- Patient outreach, Vandetanib
- Where
- 66 sites in Australia, Austria and 18 more
- Volunteers
- 205 people
- Sponsor
- Sanofi
Breast Cancer, Early Detection of Cancer
A Prospective Study to Evaluate Clinical Performance of Thermalytix in Detecting Breast Cancers
The purpose of this study is to determine the clinical performance of AI-based Thermalytix with the current standard-of-care diagnostic modalities in women.
- Trial name
- NCT04688086
- Testing
- Thermalytix
- Where
- India
- Volunteers
- 687 people, healthy volunteers welcome
- Sponsor
- Niramai Health Analytix Private Limited
Breast Cancer
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer
The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.
- Trial name
- NCT03491917
- Testing
- DBT plus S-View, FFDM alone
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fujifilm Medical Systems USA, Inc.
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
Fluid Loss
Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure.
- Trial name
- NCT05463198
- Testing
- CM-1600
- Where
- 4 sites in United States
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- Zynex Monitoring Solutions
Coronary Artery Disease
Perfusion Imaging and CT -Understanding Relative Efficacy
To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.
- Trial name
- PICTURE (NCT00486447)
- Testing
- 64 Channel VCT
- Where
- United States
- Volunteers
- 249 people
- Sponsor
- GE Healthcare
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
INVSENSOR00027 Fall Detection Clinical Performance Study
This study assesses INVSENSOR00027's clinical performance for fall detection.
- Trial name
- NCT04224753
- Testing
- INVSENSOR00027
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Diabetic Retinopathy
A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Diabetes affects 30.3 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy…
- Trial name
- NCT02963441
- Testing
- LumineticsCore (formerly IDX-DR)
- Volunteers
- 900 people
- Sponsor
- Digital Diagnostics, Inc.
Lyme Disease
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.
- Trial name
- NCT03581279
- Testing
- T2Lyme Panel testing
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- T2 Biosystems
Coronary Artery Disease
Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)
Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study.
- Trial name
- GadaCAD 1 (NCT01890421)
- Testing
- Gadobutrol (Gadovist, Gadavist, BAY86-4875)
- Where
- 23 sites in United States, France and 5 more
- Volunteers
- 426 people
- Sponsor
- Bayer
Embolic Stroke of Undetermined Source, Transient Ischemic Attack
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
This study is a multi-center, prospective, single-arm, non-significant risk (NSR) device study in which up to 150 evaluable subjects with suspicion of embolic stroke of undetermined source (ESUS) will be evaluated with NB-IS TCD…
- Conditions
- Embolic Stroke of Undetermined Source, Transient Ischemic Attack, Right-To-Left Atrial Shunt, Patent Foramen Ovale
- Trial name
- BUBL (NCT04604015)
- Testing
- NeuralBot Investigational System, Transthoracic Echocardiography (TTE)
- Where
- 7 sites in United States
- Volunteers
- 154 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Crohn Disease
Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.
- Trial name
- BLINK (NCT03241368)
- Testing
- Capsule Endoscopy
- Where
- 26 sites in United States, Austria and 1 more
- Volunteers
- 187 people
- Sponsor
- Medtronic - MITG
Detection of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 in Individuals Exposed to SARS-CoV-2
Assessment of Delayed-type Hypersensitivity Reactions to SARS-CoV-2 Peptide Antigens
This dose finding, multi-cohort study is designed to evaluate the safety and efficacy of intradermally-injectedTNX-2100, synthesized SARS-CoV-2 peptide antigens and assess the presence and magnitude of DTH reactions.
- Trial name
- COVID-19 DTH (NCT05216510)
- Testing
- TNX-2110, TNX-2120, TNX-2130
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Tuberculosis
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
- Trial name
- NCT02687529
- Testing
- CST001
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Deep Vein Thrombosis
Clinical Trial to Evaluate the Accuracy of [99mTc] ThromboView in the Detection of Deep Vein Thrombosis
The assessment of patients with suspected deep vein thrombosis (DVT) is a common clinical scenario that, despite major advances in diagnostic testing, continues to be challenging.
- Trial name
- NCT00123734
- Testing
- ThromboView
- Where
- 12 sites in United States, Canada
- Volunteers
- 94 people
- Sponsor
- Agen Biomedical