Clinical trials: Validity
Healthy
Oxygen Reserve Index (ORi) Validation of INVSENSOR00025
ORi is a unitless index that could help clinicians with their assessments or normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00.
- Trial name
- NCT03628898
- Testing
- INVSENSOR00025
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Healthy Volunteers
Reliability and Validity of Online Cognitive Assessments
The purpose of this study is to evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment.
- Trial name
- NCT02382393
- Testing
- Brain Performance Test (BPT, Lumos Labs, Inc), Computerized Assessment
- Where
- United States
- Volunteers
- 1,152 people, healthy volunteers welcome
- Sponsor
- Lumos Labs, Inc.
Chronic Cough
Cough Count Validation
People with respiratory infection, asthmatic patients and cystic fibrosis (CF) patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.
- Trial name
- NCT01413698
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- KarmelSonix Ltd.
High-Risk Multidisciplinary Care, Clinical Decision Support
ANCHOR Validation Trial in High-Risk Multidisciplinary Care
This pre-registered, pragmatic, three-arm (1:1:1) patient-level randomized controlled trial with mixed-effects analysis at the encounter level tests two questions in real high-risk multidisciplinary clinical encounters at the…
- Conditions
- High-Risk Multidisciplinary Care, Clinical Decision Support, Artificial Intelligence-Assisted Care, Telemedicine
- Trial name
- NCT07597499
- Testing
- Gemini 3.1 Pro with Safety Prompt, ANCHOR Clinical AI Verification Layer (with Gemini 3.1 Pro)
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Waymark
Sepsis, Shock, Septic
Sepsis Assessment in Belgian Emergency Rooms
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
- Conditions
- Sepsis, Shock, Septic, Severe Sepsis
- Trial name
- SABER (NCT02424721)
- Where
- 4 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Axis Shield Diagnostics Ltd
Refractive Errors
Investigation of the Accuracy of an Automated Refractor to Provide Well-tolerated Eyeglass Prescriptions
At the New England College of Optometry in Boston, MA, subjects ages 18-65 who have received or are receiving treatment for refractive error who choose to enroll in the study will be evaluated using subjective refraction and…
- Trial name
- NCT06883032
- Testing
- AR Eyeglasses first, SR Eyeglasses second, SR Eyeglasses first, AR Eyeglasses second
- Where
- United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- PlenOptika, 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
COPD
Loop Band Validation Study
The main purpose of this study is to assess the accuracy of a non-invasive wearable technology in the form of a wristband.
- Trial name
- NCT03240926
- Testing
- Loop Band
- Where
- United States
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- Spry Health
Coronary Artery Disease, Coronary Arteriosclerosis
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
- Trial name
- VICTORY (NCT01856504)
- Where
- 7 sites in United States, Argentina and 3 more
- Volunteers
- 218 people
- Sponsor
- MDDX LLC
Healthy Volunteers
Donation of Whole Blood by Healthy Volunteers After Mobilisation by Haematopoietic Growth Factor (Rhu-G-CSF = Granocyte)
Donation of whole blood by healthy volunteers after mobilisation by haematopoietic growth factor (rhu-G-CSF = Granocyte) for biological validation of a cell expansion automaton allowing the simultaneous production of several cell…
- Trial name
- CARDIOSTEM (NCT05594433)
- Testing
- Lenograstim
- Where
- 2 sites in France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CellProthera
Asthma in Children, Bronchitis
Clinical Validation of Omron WheezeScan
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
- Conditions
- Asthma in Children, Bronchitis, Bronchiolitis
- Trial name
- NCT04144699
- Where
- 15 sites in United States
- Volunteers
- 240 people
- Sponsor
- Omron Healthcare Co., Ltd.
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
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.
Anesthesia
Pleth Variability Index (PVI) to Predict Fluid Responsiveness
Interventional data collection study to evaluate the ability of pleth variability index (PVI) to predict fluid responsiveness in comparison with other dynamic parameters including pulse pressure variation (PPV) and stroke volume…
- Trial name
- NCT03120910
- Testing
- Pulse CO-Oximeter Sensor
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Masimo Corporation
Spine Disease, Spinal Fusion
Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green…
- Conditions
- Spine Disease, Spinal Fusion, Surgery, Spine Degeneration
- Trial name
- DeepSurgery (NCT05166018)
- Testing
- SuMO Patient
- Where
- 2 sites in France
- Volunteers
- 174 people
- Sponsor
- Cortexx Medical Intelligence
Breast Cancer
Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.
- Trial name
- NCT00551278
- Testing
- GeneSearch™ Breast Lymph Node (BLN) Assay
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Janssen Diagnostics, LLC
Systemic Inflammatory Response Syndrome (SIRS), Sepsis
IMproved PREdiction of Severe Sepsis in the Emergency Department
The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock
- Trial name
- IMPRESSED (NCT01392508)
- Where
- 5 sites in United States, Sweden
- Volunteers
- 759 people
- Sponsor
- Axis Shield Diagnostics Ltd
Glioma, Malignant, Computer-Assisted
Radiomics-Based Visualization and Quantitative Validation of IDH1 Heterogeneity in Gliomas
The goal of this clinical trail is to non-invasively visualise and quantitatively validate an radiomics model of genetic heterogeneity in adult patients with diffuse glioma to help clinicians better guide surgical resection and…
- Trial name
- NCT05969691
- Testing
- Validation of IDH1 mutations from the radiomics model
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Mingge LLC
Ultrasound Imaging of Anatomical Structures
A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to evaluate the clinical performance of ScanNav Anatomy PNB when highlighting anatomical structures during UGRA…
- Trial name
- NCT04906018
- Testing
- Ultrasound scans
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IntelligentUltrasound Limited
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.