Clinical trials: VALİDİTY
Epilepsy, Seizures
EpiCare@Home Validation Study for Focal Onset Seizures
The goal of this clinical trial is to validate a wearable seizure monitoring device, EpiCare@Home, as an objective seizure monitoring tool for people with focal onset epileptic seizures.
- Conditions
- Epilepsy, Seizures, Seizures, Focal, Seizure, Refractory
- Trial name
- NCT05738226
- Testing
- EpiCare@Home, wearable multimodal seizure monitoring system
- Where
- United States
- Sponsor
- Byteflies
SpO2 (Peripheral Oxygen Saturation) Measurement Validation, SpO2
SpO2 Infant and Pediatric Study
This study evaluates the pulse oximetry (SpO₂) sensor for clinical performance, form, and fit in hospitalized infants and children (28 days to 12 years).
- Trial name
- SpO2 Peds (NCT07615738)
- Testing
- SpO2 Sensor
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- GE Healthcare
Colorectal Neoplasms, Colonic Polyps
Clinical Validity Verification on Diagnostic Assistance for Presence and Severity of Colorectal Cancer and Polyps Using Artificial Intelligence-based Medical Device Software Endoscopic Imaging Assistance
This completed retrospective study evaluated the clinical performance of ENAD-CADx-01, an artificial intelligence-based medical device software intended to assist healthcare professionals in characterizing colorectal lesions in…
- Conditions
- Colorectal Neoplasms, Colonic Polyps, Hyperplastic Polyps, Sessile Serrated Lesions
- Trial name
- NCT07744607
- Where
- South Korea
- Volunteers
- 1,114 people
- Sponsor
- Ainex Corporation
Healthy
Clinical Validation of the Norbert Health Device for Pulse Rate Measurement at Vigilant Clinical Testing
The study will evaluate the measuring pulse rate (PR) using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).
- Trial name
- NCT06917352
- Testing
- Norbert Device
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Norbert Health
Lymphoma, Non-Hodgkin
Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade…
- Trial name
- RIT-II-001 (NCT01224821)
- Testing
- Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Fetal Anomaly
Validation of a Test for Fetal Malformations
The investigators have developed a diagnostic test for the evaluation of the presence of fetal malformations through metabolomic analysis of maternal peripheral blood serum by chromatographic techniques and mass spectrometry, and…
- Trial name
- NCT02965287
- Testing
- Serum metabolomics profiling
- Where
- Italy
- Volunteers
- 1,943 people, healthy volunteers welcome
- Sponsor
- Theoreo Srl
Prostate Cancer
Prospective Validation of Prostate Biomarkers for Repeat Biopsy
Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy scheduled for repeat biopsy. Subjects must have had their negative index prostate biopsy procedure within 30 months of being scheduled for…
- Trial name
- PRIORITY (NCT03082274)
- Testing
- ConfirmMDx, SelectMDx
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- MDx Health
Chronic Cough
Validation and Evaluation of a Novel Cough Detection Device
When diagnosing chronic cough (cough lasting longer than 8 weeks), the physician nowadays very often relies on the patient's narrative and description.
- Trial name
- NCT04861155
- Testing
- SIVA-P3
- Where
- Switzerland
- Volunteers
- 29 people
- Sponsor
- Evoleen AG
Brain Injuries, Craniocerebral Trauma
Assessment of Head Injury in the Emergency Department Using BrainScope® Ahead® Technology
The objectives of the study are to document device performance with respect to the primary and secondary endpoints.
- Trial name
- B-AHEAD II (NCT01556711)
- Where
- 11 sites in United States
- Volunteers
- 816 people
- Sponsor
- BrainScope Company, Inc.
Asthma
Validation of Structured Light Plethysmography: Asthma
Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in…
- Trial name
- SLPBD (NCT02543333)
- Where
- 2 sites in United Kingdom
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Pneumacare Ltd
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
Healthy, Breast Cancer
Validation of a Tear-based Screening Assay for Breast Cancer
This study will explore and better understand the value, usage, and benefits of a tear-based screening test for breast cancer as a supplemental tool for screening mammograms.
- Conditions
- Healthy, Breast Cancer, Breast Cancer Female, Health Care Utilization
- Trial name
- NCT04928014
- Testing
- Schirmer Strip
- Where
- United States
- Volunteers
- 205 people, healthy volunteers welcome
- Sponsor
- Namida Lab
Depression Disorders, Anxiety Disorders
Pivotal U.S. Clinical Validation of AI-COA® for Depression and Anxiety
This study is a large-scale pivotal clinical validation of the AI-COA® software device. The purpose is to confirm the tool's accuracy and performance across a demographically diverse population of adults with Major Depressive…
- Trial name
- SEQUOIA-3 (NCT07279038)
- Where
- United States
- Volunteers
- 650 people
- Sponsor
- Deliberate Solutions Inc.
Colorectal Cancer
Pre-Clinical Validation of ChemoINTEL Unified Algorithm Chemotherapeutic Response Prediction in Patients With Colorectal Cancer
This is a prospective, non-randomized, observational, pre-clinical validation study. Pierian Biosciences is utilizing ChemoINTEL assay measured in vitro cytotoxic drug induced apoptosis and cell death in isolated fresh human…
- Trial name
- NCT07830407
- Where
- United Kingdom
- Volunteers
- 100 people
- Sponsor
- Pierian Biosciences
Blood Pressure, Cardiac Output
Caretaker Hemodynamic Parameters Validation
Comparison studies comparing hemodynamic parameters provided by the Caretaker against respective Gold Standard references.
- Conditions
- Blood Pressure, Cardiac Output, Left Ventricular Ejection Time, Heart Rate Variability
- Trial name
- NCT04685733
- Testing
- Non-invasive hemodynamic measurements
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- CareTaker Medical LLC
Healthy
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG.
- Trial name
- NCT07223164
- Testing
- Masimo SET® and Masimo W1®
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Influenza
Rapid Diagnostic Test for Influenza
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT01089816
- Testing
- Local/Regional Public Health Notification
- Where
- 4 sites in Vietnam
- Volunteers
- 569 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Influenza A, Influenza B
Covid Flu A/B and RSV 4 in 1 Diagnostic Test
The goal of this observational study is to evaluate the diagnostic performance of an investigational Flu A/B, COVID-19 and RSV test in patients with signs and symptoms of respiratory infection.
- Conditions
- Influenza A, Influenza B, COVID - 19, RSV
- Trial name
- NCT07308158
- Testing
- Investigational Flu A/B Covid-19 and RSV Diagnostic Test
- Where
- 23 sites in United States, Puerto Rico
- Volunteers
- 1,119 people
- Sponsor
- iHealth Labs inc
Allergic Rhinoconjunctivitis, Allergic Asthma
Validation of Combined Symptom Medication Score (cSMS) in Allergic Patients
The CSMS was defined by the European Academy of Allergy and Immunology Taskforce as a standardised tool to assess clinical effects of allergen-specific immunotherapy (AIT).
- Trial name
- NCT03850626
- Testing
- Immunotherapy
- Where
- Germany
- Volunteers
- 168 people
- Sponsor
- Leti Pharma GmbH
Alzheimer Disease, Mild Cognitive Impairment
Software Validation Study-Cognitive Status Indicator
The SPARK Cognitive Status Indicator software uses an algorithm to assess a resting state EEG recording as being consistent with a cognitive status of unimpaired, mild cognitive impairment (MCI; MCI AD- or MCI AD+), or dementia…
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Trial name
- REMIND-V (NCT06809725)
- Testing
- SPARK Cognitive Status Indicator (software support data collected via EEG)
- Where
- United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Spark Neuro Inc.