Clinical trials: Validation Studies
Atrial Fibrillation, Arrythmia, Cardiac
Validation Study of the Watch HWA09 and Its Softwares ECG-SW1 and PPG-SW1 for the Detection of Atrial Fibrillation
The proposed clinical study aims to validate the diagnostic performance, compared to a reference ECG, of the ECG-SW1 software and the PPG-SW1 software integrated into the HWA09 watch developed by Withings for the automatic…
- Trial name
- WEFA (NCT04351386)
- Testing
- AF Detection
- Where
- 3 sites in France
- Volunteers
- 283 people
- Sponsor
- Withings
Psychological Well Being
Digital Self-Assessment of Well-Being: Validation of the Libellules Tool Against Gold-Standard Psychological Scales
The Libellules (WB6Dim) study aims to validate a digital self-assessment tool for measuring individual well-being across six dimensions: sleep and recovery, emotional climate, self-esteem, perceived autonomy, energy reservoir…
- Trial name
- NCT07301879
- Where
- France
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Clover Link
Pain, Otitis Media
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
- Trial name
- NCT01588535
- Testing
- benzocaine
- Where
- 15 sites in United States
- Volunteers
- 38 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Cardiovascular Diseases, Hypertension
Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of…
- Trial name
- eXPLORE (NCT05580068)
- Testing
- Hypertension therapy through iATROS medical device
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- iATROS GmbH
Vital Sign Evaluation
Respiratory Rate Validation Study - Mindset Medical Informed Vital Core Application
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform. This single-arm cohort, open-label study is designed to evaluate the accuracy of a web-based application designed for measurements of vital…
- Trial name
- NCT06508047
- Testing
- Informed Vital Core App
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Mindset Medical
HIV Infections
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
- Trial name
- NCT00504452
- Testing
- KP-1461
- Where
- 31 sites in United States, Puerto Rico
- Volunteers
- 27 people
- Sponsor
- Koronis Pharmaceuticals.
Subjects Presenting With Normal Eyes
TopQ Cut-off Score Validation Study for 3D OCT-1 Maestro
The objective of this study is to validate the TopQ cutoff scores, which have been previously determined.
- Trial name
- NCT02447133
- Testing
- 3D OCT-1 Maestro
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Topcon Medical Systems, Inc.
Uterine Fibroids, Uterine Leiomyomas
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment.
- Trial name
- NCT00295217
- Testing
- ExAblate 2000
- Where
- 4 sites in United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- InSightec
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
Gaucher Disease
A Study Measuring Substances Potentially Indicating Bone Problems in Adults With Type 1 Gaucher Condition
Substances in the body, so-called biomarkers, can help predict the severity of Gaucher disease (GD)-related bone problems in adults.
- Trial name
- NCT05702814
- Testing
- No Intervention
- Where
- Spain
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Takeda
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
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
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.
Burns, Wound Heal
Burn Validation Study
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
- Conditions
- Burns, Wound Heal, Wounds and Injuries
- Trial name
- BVS (NCT06131203)
- Testing
- DeepView SnapShot Portable (DV-SSP)
- Where
- 21 sites in United States
- Volunteers
- 274 people
- Sponsor
- SpectralMD
Clinical Indication for Brain MRI, Healthy Volunteers
Comparative Study of Conventional MR Images With Synthetically Reconstructed MR Images of the Brain
This study is being conducted for evaluation of 3D Synthetic MRI (SyMRI 15, 3D) for neuroimaging,
- Trial name
- NCT05425927
- Testing
- SyMRI 15 (3D)
- Where
- 6 sites in United States
- Volunteers
- 189 people, healthy volunteers welcome
- Sponsor
- SyntheticMR
Osteoarthritis of the Small Joints of the Hand
Clinical Validation Study of Personalized Orthopedic Splints With 3D Technology in Patients With Rhizarthrosis
Osteoarthritis of the hand is a chronic joint disease that usually affects one or more of the finger joints and it is a major cause of disability.
- Trial name
- NCT04678622
- Testing
- Bioferula3D
- Where
- 2 sites in Spain
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Optimus3D S.L.
Myelodysplastic Syndromes, Leukemia Myeloid Acute
A Study to Determine Final Geriatric Assessment in Haematology (GAH) Score as a Tool for Predicting Tolerance to Treatment in Elderly Patients (≥ 65 Years) With Haematologic Neoplasms
This is a post-authorization, retrospective multicentre observational nationwide study (PAS-OD). It will be conducted by reviewing medical records and database of patients who participated in the validation of the psychometric…
- Conditions
- Myelodysplastic Syndromes, Leukemia Myeloid Acute, Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
- Trial name
- NCT02842229
- Where
- 15 sites in Spain
- Volunteers
- 117 people
- Sponsor
- Celgene
Acromegaly
Validation Study of the SAGIT® Instrument in Acromegaly
Patients will be treated in accordance with the standard medical practice of the hospital where they have been recruited during their participation in this study. No additional assessments or tests will be required.
- Trial name
- SAGIT (NCT02539927)
- Where
- 33 sites in United States, Belgium and 8 more
- Volunteers
- 227 people
- Sponsor
- Ipsen
Rheumatoid Arthritis, Psoriatic Arthritis
A Study to Test the Design, Functionality, and Ergonomic Features of the Autoinjector
The main purpose of this study is to evaluate how well the autoinjector works in a group of people who are likely to use the autoinjector for injecting their medicine in the future.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Psoriasis
- Trial name
- NCT00643526
- Where
- 2 sites in United States
- Volunteers
- 68 people
- Sponsor
- Centocor, Inc.
Atrial Fibrillation
ECG App Algorithms Clinical Validation Study
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates
- Trial name
- NCT04247581
- Testing
- 1-lead ECG
- Where
- 4 sites in United States
- Volunteers
- 546 people, healthy volunteers welcome
- Sponsor
- Apple Inc.