Clinical trials: Validation Studies
Alzheimer Disease, MCI
Validation Study of a New Digital Treatment Test
Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems.
- Trial name
- NCT04897464
- Testing
- BGaze therapy Alzheimer
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Braingaze
Atrial Fibrillation
Atrial Fibrillation Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performances of investigational Irregular Rhythm Notification Feature (version 2.0) and Atrial Fibrillation History Feature algorithms.
- Trial name
- NCT04699812
- Testing
- ELECTROCARDIOGRAM (ECG) PATCH WEAR
- Where
- 4 sites in United States
- Volunteers
- 573 people, healthy volunteers welcome
- Sponsor
- Apple Inc.
Severe Sepsis
Symphony IL-6 Cutoff Validation Study for Patients at Risk of Severe Sepsis
Symphony IL-6 is a device that quantitates human IL-6 by fluorescence enzyme immunoassay (FEIA) from whole-blood specimens. Use of Symphony IL- 6 removes the need for plasma separation before testing.
- Trial name
- NCT05048927
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Bluejay Diagnostics, Inc.
Cardiovascular Disease
X-ray Dose Reduction Study for Endovascular Interventional Radiology
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly.
- Trial name
- NCT01599741
- Testing
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology., Normal dose DSA with conventional X-ray imaging technology
- Where
- Netherlands
- Volunteers
- 51 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Atopic Dermatitis
Scratching Validation Study
Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic…
- Trial name
- NCT05137093
- Testing
- Actigraphy Device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Malignant Melanoma
Melanoma Image Analysis Algorithm (MIAA) Validation Study
Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.
- Trial name
- NCT02612168
- Testing
- Melanoma Image Analysis Algorithm (MIAA)
- Where
- 7 sites in United Kingdom
- Volunteers
- 514 people
- Sponsor
- Skin Analytics Limited
MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
AGED Diagnostics Clinical Validation Study
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the…
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Fibrosis and Cirrhosis of Liver, MetALD
- Trial name
- NCT07867574
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
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
Hemiplegia
Atalante USAbility
The "USAbility" study - Human Factor Validation Testing of the Atalante exoskeleton aims at demonstrating that Atalante can be used by the intended users without serious use errors or problems, for the intended uses and under the…
- Trial name
- NCT05284708
- Testing
- Atalante
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wandercraft
Atrial Fibrillation
Withings ECG-app Study
The aim of the study is to evaluate the performance of Withings HWA10 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
- Trial name
- NCT05316350
- Testing
- Electrocardiogram recording
- Where
- 10 sites in United States, France
- Volunteers
- 685 people
- Sponsor
- Withings
Coronary Artery Disease, Stable Angina
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
- Trial name
- NCT07763769
- Testing
- MedHub AutocathFFR
- Where
- 4 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medhub Ltd.
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
Pathology
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
- Trial name
- NCT03992768
- Testing
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- Where
- 3 sites in United States
- Volunteers
- 540 people
- Sponsor
- Hamamatsu Photonics K.K.
Healthy
Avicena LVDP Validation Study in Healthy Volunteers
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
- Trial name
- NCT05673174
- Testing
- Non-Invasive Estimation of Left Ventricular Diastolic Pressure
- Where
- United States
- Volunteers
- 321 people, healthy volunteers welcome
- Sponsor
- Ventric Health, LLC
Non Invasive Blood Pressure
Philips Non-Invasive Blood Pressure Validation Study of VS30 Monitor
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population.
- Trial name
- NCT06980766
- Testing
- Non Invasive Blood Pressure
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Colorectal Cancer
Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "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 sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).
- Trial name
- NCT04144751
- Testing
- Blood Sample Collection
- Where
- 194 sites in United States
- Volunteers
- 23,494 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Asthma COPD
Clinical and Medico-economic Validation of the HEPHAI Solution.
In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to…
- Trial name
- VAL-HEPHAI (NCT06099145)
- Testing
- Hephaï
- Where
- 5 sites in France
- Volunteers
- 238 people
- Sponsor
- Hephai
Blood Pressure, Hypertension
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope.
- Conditions
- Blood Pressure, Hypertension, Blood Pressure, High, Blood Pressure, Low
- Trial name
- NCT06513975
- Testing
- CART BP, sphygmomanometer
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Sky Labs
Infertility
Eeva System Imaging Study
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
- Trial name
- PROSPECT (NCT02301637)
- Testing
- Eeva™ Test
- Where
- 7 sites in United States, New Zealand
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Progyny, Inc.
Blood Pressure Monitoring, Blood Pressure
Noninvasive Blood Pressure Validation Study
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff.
- Trial name
- NCT07774169
- Testing
- Chest Worn Blood Pressure Monitor
- Where
- United States
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices