Clinical trials: Validity
Stroke
Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation
Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood biomarker profile that can be used to determine stroke from no stroke in the emergency setting.
- Trial name
- VALISS (NCT02753257)
- Testing
- Non-Interventional
- Where
- 2 sites in United States
- Volunteers
- 500 people
- Sponsor
- Valtari Bio
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Allergy, Immunoglobulin E-Mediated Allergic Disorder
Kenota 1 CWS Method Comparison Validation Study
The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods.
- Trial name
- NCT05702671
- Testing
- Total Immunoglobulin E, Obtained From Fingerstick Sample
- Where
- 3 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Kenota Inc.
Contraception
Validation of Effectiveness on NaturalCycles Users
The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility.
- Trial name
- VENUS (NCT07566793)
- Testing
- Log daily intercourse information, Natural Cycles application
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Natural Cycles
Sepsis, Septic Shock
Assessment of Heparin Binding Protein for the Prediction of Severe Sepsis
The purpose of this prospective, non-interventional, multi-centre clinical study is to assess the clinical validity of the Heparin Binding Protein (HBP) assay for indicating the presence, or outcome, of severe sepsis (including…
- Conditions
- Sepsis, Septic Shock, Sepsis With Acute Organ Dysfunction
- Trial name
- NCT03113721
- Where
- 5 sites in United States
- Volunteers
- 571 people
- Sponsor
- Axis Shield Diagnostics Ltd
Heart Failure
Nanowear Heart Failure Management Multi-sensor Algorithm
The NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which…
- Trial name
- Nanosense (NCT03719079)
- Testing
- SimpleSENSE
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Nanowear Inc.
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Self Abrading Rapidly Applied Electrode Validation
The SARA (Self Abrading Rapidly Applied) electrode will speed EEG patient hookup by combining multiple steps that burden conventional EEG procedures into one.
- Trial name
- SARA (NCT02200523)
- Testing
- SARA electrode, Gold cup
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cleveland Medical Devices Inc
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Rheumatoid Arthritis
Assess Structural Damage in Rheumatoid Arthritis Using Biomarkers and Radiography
Recruited patients will include those about to begin Disease-Modifying Antirheumatic Drug) DMARD therapy or about to change DMARD therapy.
- Trial name
- NCT01476956
- Testing
- Observational study
- Where
- 36 sites in United States, Canada and 8 more
- Volunteers
- 571 people
- Sponsor
- CARE ARTHRITIS LTD.
Vaping, Underage
Human Factors Validation and Usability Testing of the IKE Age-Gating System
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity…
- Trial name
- NCT06952569
- Testing
- IKE System
- Where
- 4 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- IKE Tech
Helicobacter Infections
Endofaster Test for Helicobacter Pylori Detection in Patients on Proton Pump Inhibitor Therapy
H. pylori infection is the most important causative agent of gastritis, and subsequent atrophic gastritis. The endoscopic diagnosis of H. pylori infection relies on urease tests such as the Clo test.
- Trial name
- NCT02126722
- Testing
- Gastroscopy, EndoFaster test, Clo test
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Niso Biomed S.R.L.
Blood Pressure
Validation of the JADE wRAP™, a Novel Blood Pressure Measurement Device, Using the Same Arm Sequential Method
The JADE wRAP™, a wrist worn cuff to measure blood pressure and its supporting software platform is currently at the final alpha prototype stage of development and is not intended for sale.
- Trial name
- NCT03452280
- Where
- Canada
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Jade Healthcare Group Inc.
Heart Failure
Withings HFRN Retrospective Study
This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)
- Trial name
- NCT07654491
- Testing
- Withings Heart Function Risk Notification (HFRN), Claims-based heart-failure adjudication (reference standard)
- Where
- France
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Withings
Dental Cares Under Kalinox's Inhalation
Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares
The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.
- Trial name
- NCT00643786
- Testing
- Oxygène, Air Médical
- Where
- France
- Volunteers
- 128 people
- Sponsor
- Air Liquide Santé International
Heart Failure, Kidney Disease
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated…
- Trial name
- NCT02140905
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Baxter Healthcare Corporation
Bladder Carcinoma, Prostate Tumor
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit.
- Conditions
- Bladder Carcinoma, Prostate Tumor, Gallbladder Carcinoma, Endometrial Carcinoma
- Trial name
- REMOVE (NCT06789224)
- Testing
- CATUVAB
- Where
- 6 sites in Germany
- Volunteers
- 136 people
- Sponsor
- Lindis Bloodcare GmbH
Myopia
Comparison of New Contact Lens With Current Marketed Lens
The purpose of this study is to validate the clinical performance of a new contact lens design.
- Trial name
- NCT03360110
- Testing
- Phoebe test lens, stenfilcon A lens (control)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- CooperVision, Inc.
Ultrasound Imaging of Anatomical Structures
Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination
This study conducted at three locations, aiming to collect ultrasound images from volunteers and assess the performance of an AI software, MSK Go, using these images.
- Trial name
- NCT07336407
- Testing
- Ultrasound Scans
- Where
- 3 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Smart Alfa Teknoloji San. ve Tic. A.S.
Arrhythmias, Cardiac, Atrial Fibrillation
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Bradycardia
- Trial name
- VALID-ECG (NCT06123130)
- Testing
- Vectorcardiography (VECG)
- Where
- 5 sites in United States
- Volunteers
- 198 people
- Sponsor
- HeartBeam, Inc.
Cirrhosis, Liver, Hepatic Cirrhosis
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis…
- Conditions
- Cirrhosis, Liver, Hepatic Cirrhosis, Hepatocellular Carcinoma, Liver Cancer
- Trial name
- NCT03804593
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Epigenomics, Inc