Clinical trials: System Validation
Health Volunteer Validation Study
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
This study has the following objective: To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
- Trial name
- ViVUS (NCT02975050)
- Testing
- Location
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zoll Medical Corporation
Validation of Oximeter System
Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.
- Trial name
- NCT01908790
- Testing
- Mespere Venous Oximeter, Avoximeter 4000
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Mespere Lifesciences Inc.
Healthy, Sleep Deprivation
Smart Sleep In-home Validation Extension Study
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting.
- Conditions
- Healthy, Sleep Deprivation, Insufficient Sleep Syndrome
- Trial name
- NCT03665844
- Testing
- SmartSleep Boost On, SmartSleep Boost Off
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Philips Respironics
Colorectal Cancer
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
- Trial name
- NCT04144738
- Testing
- mt-sDNA 2.0 screening test, FIT test, Colonoscopy
- Where
- 195 sites in United States
- Volunteers
- 26,758 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Breast Cancer
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
- Trial name
- NCT00756834
- Testing
- Screening
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions
Obstructive Sleep Apnea
Validation of a Simplified MATRx Plus
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing.
- Trial name
- NCT03812692
- Testing
- MATRx plus
- Where
- Canada
- Volunteers
- 59 people
- Sponsor
- Zephyr Sleep Technologies
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
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.
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.
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.
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
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
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Colo-rectal Cancer, Cancer Colon
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early.
- Conditions
- Colo-rectal Cancer, Cancer Colon, Cancer, Rectum, Neoplasms,Colorectal
- Trial name
- NCT03688906
- Where
- 30 sites in United States, Canada
- Volunteers
- 3,275 people, healthy volunteers welcome
- Sponsor
- Freenome Holdings Inc.