Clinical trials: Validation Studies
Cardiac Arrhythmia
Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the…
- Trial name
- NCT07205367
- Testing
- Zio Monitor
- Where
- 2 sites in United States
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- iRhythm Technologies, Inc.
Pathology
Instrument Precision Study for Validation of Philips Dx
The objective of this study is to evaluate precision of the Philips Dx system.
- Trial name
- NCT02699970
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Opioid Use Disorder
Assessment of Methadone and Buprenorphine in Interstitial Fluid
The purpose of this research is to determine if common medications for opioid use disorder (i.e., buprenorphine/naloxone, buprenorphine, methadone) and their metabolites (norbuprenorphine [a metabolite of buprenorphine]…
- Trial name
- NCT05546229
- Testing
- Microneedle based interstitial fluid collection
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Cari Health Inc.
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
Myopia
Comparison of New Contact Lens With Current Marketed Lens
The purpose of this study is to validate the clinical performance of a new contact lens design.
- Trial name
- NCT03360110
- Testing
- Phoebe test lens, stenfilcon A lens (control)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- CooperVision, Inc.
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
Cardiopulmonary Disease
Respiration Validation for CPM Device
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized.
- Trial name
- NCT05445492
- Testing
- CPM Device
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Oxygen Deficiency
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
- Trial name
- NCT04584788
- Testing
- Masimo O3 Regional Oximeter
- Where
- Netherlands
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Autism Spectrum Disorder
Cognoa ASD Diagnosis Aid Validation Study
The primary objective of this study is to collect data to ascertain the Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the current version of the Cognoa diagnostic device.
- Trial name
- NCT04151290
- Testing
- Cognoa ASD diagnostic device
- Where
- 16 sites in United States
- Volunteers
- 711 people
- Sponsor
- Cognoa, Inc.
Dementia, Alzheimer Disease
The Brain Health Study: A Pragmatic, Patient-Centered Trial
The eRADAR Brain Health Study seeks to refine and test a novel, low-cost strategy for increasing dementia detection within primary care.
- Trial name
- NCT05356702
- Testing
- Brain Health Assessment
- Where
- 5 sites in United States
- Volunteers
- 3,417 people, healthy volunteers welcome
- Sponsor
- Kaiser Permanente
This is a Pilot Study Which Aims to Assess the Validity and Applicability of Lateral Flow Assays (LFAs) Which Can be Used as a Point of Care Test for COVID-19, Covid19
The LAVA (Lateral Flow Antigen Validation and Applicability) Study for COVID-19
This is a pilot study which aims to assess the validity and applicability of lateral flow assays (LFAs) which can be used as a point of care test for COVID-19.
- Trial name
- LAVA (NCT04629157)
- Testing
- Innova Lateral Flow Device
- Where
- 2 sites in United Kingdom
- Volunteers
- 400 people
- Sponsor
- Alder Hey Children's NHS Foundation Trust
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
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Body Composition
Hydration Factor Study for the Stayhealthy BC3
This was a pilot study to validate the BC3 hydration factor which will be important for determining how well this value represents hydration status compared to assessment of total body water by D20.
- Trial name
- NCT01209936
- Testing
- D2O
- Where
- United States
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Dyspepsia
Carbon-13 (13C)-Spirulina Platensis Gastric Emptying Breath Test (GEBT)
The purpose of this study is to compare stomach emptying using 13C-Spirulina platensis breath test and scintigraphy in healthy subjects and subjects with dyspepsia.
- Trial name
- NCT01248221
- Testing
- [13C]-Spirulina platensis and 99mTc sulfur colloid
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia
Biomarkers in Predicting Treatment Response to Sirolimus and Chemotherapy in Patients With High-Risk Acute Myeloid Leukemia
This pilot phase II trial studies whether biomarkers (biological molecules) in bone marrow samples can predict treatment response to sirolimus and chemotherapy (mitoxantrone hydrochloride, etoposide, and cytarabine [MEC]) in…
- Conditions
- Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
- Trial name
- NCT02583893
- Testing
- Sirolimus, Mitoxantrone, Etoposide
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Tobacco Dependence
UW Withdraw From Tobacco Study
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success.
- Trial name
- NCT04969198
- Testing
- Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
- Where
- United States
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison