Clinical trials: Validation Studies
Device Validation of In-vivo Performance
An In Vivo 24-Hour Recovery Study of Whole Blood by the Reveos System
This is an in vivo 24-hour recovery study of leukoreduced red blood cells (RBCs) after automated separation of whole blood by the Reveos Automated Blood Processing System and storage for 42 days.
- Trial name
- NCT05239455
- Testing
- Reveos® Automated Blood Processing System
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Terumo BCT
Dietary Habits
PortionSize Study 3: Assessment in Free-living Conditions
The objective is to test the accuracy of the PortionSize™ app and the MyFitnessPal© app at measuring energy intake in free-living conditions, tested against the gold-standard, doubly labeled water.
- Trial name
- NCT05906160
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Pennington Biomedical Research Center
Atopic Dermatitis
Validation of the Short-term Antimicrobial Action of Transplanted Bacteria
Unlike healthy control skin, the skin of patients with atopic dermatitis (AD) is frequently colonized by Staphylococcus aureus (S. aureus), putting these patients at increased risk of S. aureus skin infections.
- Trial name
- NCT01959113
- Testing
- Autologous Microbiome Transplant
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of California, San Diego
Obstructive Sleep Apnea
PMP-300E (Smart Watch): Portable Monitoring Device Study
Validation of Portable Monitoring Device PMP-300E for Identification of Obstructive Sleep Apnea.
- Trial name
- PMP-300E (NCT01364740)
- Testing
- PMP-300E, In-lab PSG
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Stanford University
Rhinitis, Allergic, Perennial
Validation Of Preference Module Of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)
The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for…
- Trial name
- NCT00346775
- Testing
- Beclomethasone dipropionate, Flunisolide
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- GlaxoSmithKline
Obstructive Sleep Apnea
Belun Ring Validation Study for Assessment of Obstructive Sleep Apnea
This study aims to determine the overall accuracy, sensitivity, and specificity of the Belun Ring device in evaluating obstructive sleep apnea by comparing the device to the attended overnight in-lab polysomnography which is the…
- Trial name
- NCT03997916
- Testing
- Belun Ring, PSG
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Pediatric Congenital Heart Surgery
Predictive Value of the FORE-SIGHT™ Monitor for Hemodynamic Deterioration
The postoperative period after congenital heart surgery in children can be a very critical episode, where it is of utmost importance to closely monitor the circulation in these patients.
- Trial name
- NCT01706497
- Testing
- Cerebral tissue oxygen saturation monitoring, blinded
- Where
- Belgium
- Volunteers
- 300 people
- Sponsor
- KU Leuven
Validation Studies
d13C Added Sugar Intake Biomarker: Determining Validity in Children
Added sugars (AS) constitute a significant source (~ 16%) of the total daily calories consumed by youth. The role of AS in health is contentious, and the reliance on self-reported dietary data is an often-cited flaw in existing…
- Trial name
- NCT02455388
- Testing
- High added sugar diet, Low added sugar diet
- Where
- United States
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- Virginia Polytechnic Institute and State University
Coronary Artery Disease
Validation of a Vital Signs Monitoring Wristband
Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home…
- Trial name
- MULTI-VITAL (NCT05566886)
- Testing
- Continuous measurement of photoplethysmography at the wrist
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Corsano Health B.V.
Helicobacter Pylori Infection
Exalenz Lab Mode System Compared to Biopsy for H.Pylori Detection
The Exalenz Dual Mode BreathID® Hp System comprised of IDkit: Hp™ TWO and the Dual Mode BreathID® Hp test device will be used to perform a urea breath test in the initial diagnosis and post treatment monitoring of H.pylori…
- Trial name
- NCT02528721
- Testing
- Dual Mode BreathID Hp System
- Where
- 13 sites in United States, Israel
- Volunteers
- 282 people
- Sponsor
- Meridian Bioscience, Inc.
Bipolar Disorder, Alcoholism
Adjunctive Topiramate for Treatment of Alcohol Dependence in Patients With Bipolar Disorder
The purpose of this study is determine whether the use of topiramate is effective in the treatment of alcohol dependence (i.e. decreases drinking) in patients with bipolar disorder.
- Conditions
- Bipolar Disorder, Alcoholism, Alcohol Dependence
- Trial name
- NCT00572117
- Testing
- Topiramate
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery
Assisted Fluid Management IDE Study
The primary objective of this study is to evaluate the performance of the Acumen™ Assisted Fluid Management (AFM) Feature in its ability to predict a subject's fluid responsiveness.
- Conditions
- Non-Cardiac/ Non-Thoracic Surgery, Abdominal Surgery, Pelvic Surgery, Major Peripheral Vascular Surgery
- Trial name
- AFM (NCT03469570)
- Testing
- EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature
- Where
- 10 sites in United States
- Volunteers
- 330 people
- Sponsor
- Edwards Lifesciences
Gout
Validation Study of Physical Measurement of Tophi
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
- Trial name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
Blood Pressure
Comparison of Non-Invasive Blood Pressure Methods
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer.
- Trial name
- NIBP (NCT04296227)
- Testing
- The Vital Detect blood pressure monitor
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Vital USA, Inc.
Pathology
Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for…
- Trial name
- NCT03991468
- Testing
- Whole Slide Imaging, Light Microscopy
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Hamamatsu Photonics K.K.
Vascular Diseases
X-ray Dose Reduction Study for Cardiac Angiography and Intervention
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
- NCT01684826
- Testing
- Angiographic run with new algorithm and low dose (50% dose), Angiographic run with predecessor algorithm and dose (100%)
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Dementia, Alzheimer Disease
The Brain Health Study: A Pragmatic, Patient-Centered Trial
The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.
- Trial name
- eRADAR (NCT05905796)
- Testing
- Brain Health Assessment
- Where
- 3 sites in United States
- Volunteers
- 1,261 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Healthy Male Adults Participants, Vasectomy
Plan A Novel Delivery Device Study
This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.
- Trial name
- NCT06891729
- Testing
- Delivery Lumen Access Device, DLAD
- Where
- 2 sites in Australia, Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Next Life Sciences
Pathologic Processes
Pivotal Study for Validation of Philips Dx (PDx)
The primary objective of this study is to show safety and effectiveness of the PDx for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical pathology slides.
- Trial name
- NCT02529137
- Where
- 4 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Philips Digital & Computational Pathology
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.