Clinical trials: Validation Studies
Clostridium Difficile Infection
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument.
- Trial name
- NCT02968758
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 7 sites in United States, Canada
- Volunteers
- 2,461 people
- Sponsor
- Meridian Bioscience, Inc.
Hypogonadism, Male
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult hypogonadal male subjects.
- Trial name
- DV (NCT03242590)
- Testing
- LPCN 1021
- Volunteers
- 95 people
- Sponsor
- Lipocine Inc.
Keratoconjunctivitis Sicca
TearLab Core Validation Study to Establish Referent Values for Dry Eye Disease
This is a prospective, observational case series to determine the clinical utility of tear osmolarity and other commonly used objective tests to diagnose dry eye disease, as well as to establish referent values for objective…
- Trial name
- CVS (NCT00848198)
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 314 people, healthy volunteers welcome
- Sponsor
- TearLab Corporation
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Diabetic Retinopathy
RETeval Study for Diabetic Retinopathy
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy.
- Trial name
- NCT01950663
- Testing
- RETeval
- Where
- 2 sites in United States
- Volunteers
- 468 people
- Sponsor
- Inoveon Corporation
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Lung Neoplasms
Validation of Molecular Diagnostic Thecnologies for Lung Cancer Patients.
This is a non-interventional multi-center with investigational sites in Chile and Brasil diagnostic study to validate novel diagnostic technologies, such as Next Generation Sequencing (NGS) from both tissue and blood compared to…
- Trial name
- NIRVANA (NCT03220230)
- Where
- 37 sites in Brazil, Chile and 1 more
- Volunteers
- 4,240 people
- Sponsor
- Pfizer
Cardiovascular Diseases, Blood Pressure
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks.
- Conditions
- Cardiovascular Diseases, Blood Pressure, Hypertension
- Trial name
- NCT06560034
- Testing
- VicorderCS
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- 80 Beats Medical
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
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.
Rheumatoid Arthritis
Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants
The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II.
- Trial name
- NCT02485483
- Where
- 10 sites in Germany
- Volunteers
- 1,292 people
- Sponsor
- Hoffmann-La Roche
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
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
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
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.