Clinical trials: Validation Studies
Healthy
RDP Reliability Study
This is an observational study designed to assess the reliability and consistency of the Optina awAIrTM CAS Test for detecting phenotypic changes in the retina that are associated with beta-amyloid status (positive or negative).
- Trial name
- NCT06057493
- Testing
- Retinal Imaging with Optina4C Camera
- Where
- Canada
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
Congestive Heart Failure
Assess Measurements of Wireless Cardiac Output Device
Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality.
- Trial name
- Remote-CO-1 (NCT02252757)
- Testing
- CoVa
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Aventyn, Inc.
Congestive Heart Failure, Ischemic Cardiomyopathy
Cardiac Output Pulmonary Arterial Catheter Compared to FloWave™ 1000
The purpose of this study is to compare cardiac output results obtained using the thermodilution push technique with the Pulmonary Arterial Catheter (PAC) to the predicted cardiac output results obtained from the non-invasive…
- Conditions
- Congestive Heart Failure, Ischemic Cardiomyopathy, Mitral Valve Prolapse, Mitral Regurgitation
- Trial name
- NCT00665301
- Where
- 3 sites in United States
- Volunteers
- 54 people
- Sponsor
- Woolsthorpe Technologies, LLC
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
Diabetic Retinopathy, Diabetic Macular Edema
OphtAI Diagnostic Performance Validation for Automated Screening of Eye Diseases
Evolucare OphtAI is a medical device offering automated, artificial intelligence powered, screening capabilities for Diabetic Retinopathy, Diabetic Macular Edema, Glaucoma, ARM and AMD, whose performances will by tested through…
- Conditions
- Diabetic Retinopathy, Diabetic Macular Edema, Age-Related Macular Degeneration, Age-related Maculopathy
- Trial name
- OPHTAI-EVAL (NCT05752045)
- Testing
- Eye Fundus Double Capture for Eye Diseases Screening with OphtAI Medical Device
- Where
- 12 sites in France
- Volunteers
- 1,389 people
- Sponsor
- Evolucare Technologies
SARS-CoV
Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care (POC) test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens (nasopharyngeal swabs…
- Trial name
- EasyCov (NCT04583319)
- Testing
- EasyCov POC
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Firalis SA
Growth Hormone Deficiency
Comparative Validation of the Growth Hormone Releasing Hormone and Arginine Test for the Diagnosis of Adult Growth Hormone Deficiency
The aim of the study is to determine the specificity and sensitivity of the combined growth hormone releasing hormone (GHRH) + Arginine test in healthy volunteers, subjects with highly probable adult growth hormone deficiency…
- Trial name
- NCT01060488
- Testing
- GHRH+Arg, GHRH+Arg, ITT, ITT, ITT, GHRH+Arg.
- Where
- France
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
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.
Social Anxiety Disorder (SAD)
A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.
This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100, for the treatment of Social Anxiety Disorder (SAD).
- Trial name
- BVR-100-102 (NCT06037668)
- Testing
- BVR-100, BES-100
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- Sumitomo Pharma America, Inc.
Skin Diseases, Skin Condition
Pilot Study: AI Algorithm for Dermatology Referral Optimization
The goal of this observational prospective and analytical study is to validate that the device is a valid tool for improving the adequacy of referrals to dermatology.
- Trial name
- DAO_DERIVATION (NCT06228014)
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- AI Labs Group S.L
Cardiac Arrythmias, Valve Heart Disease
FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients.
- Conditions
- Cardiac Arrythmias, Valve Heart Disease, Cardiac Ischemia
- Trial name
- FRAILTY-CW2 (NCT06930833)
- Testing
- Corsano CardioWatch 287-2
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Corsano Health B.V.
Schizophrenia
Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia
The purpose of this study is to establish and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with…
- Trial name
- PRE-COG (NCT00358852)
- Testing
- No intervention
- Volunteers
- 2,339 people
- Sponsor
- Janssen-Cilag, S.A.
Urinary Tract Infections, Proteinuria
Scanadu Urine Device Validation Study Protocol
This study will test Scanadu Urine Device for clinical performance and usability.
- Conditions
- Urinary Tract Infections, Proteinuria, Ketone Urine, Hematuria
- Trial name
- NCT02973178
- Testing
- Scanadu Urine Device
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Scanadu, Inc.
BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms
BE Technologies Mobile Uroflowmetry Validation Study
This research study is studying MenHealth Mobile Uroflowmetry as a diagnostic tool for LUTS (lower urinary tract symptoms), a group of conditions involving the bladder, urinary sphincter, urethra and the prostate.
- Conditions
- BPH, BPH With Urinary Obstruction With Other Lower Urinary Tract Symptoms, BPH Without Urinary Obstruction, BPH Without Urinary Obstruction With Other Lower Urinary Tract Symptoms
- Trial name
- NCT04599283
- Testing
- MenHealth Uroflowmeter
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- BE Technologies Inc
Acute Respiratory Infections (ARIs)
FebriDx® Pediatric Validation Study
The primary objective of this study is to determine performance characteristics of the FebriDx® test in differentiating bacterial from non-bacterial etiology among febrile pediatric patients (2-11 years) presenting to the…
- Trial name
- NCT07211997
- Testing
- FebriDx
- Where
- 10 sites in United States
- Volunteers
- 800 people
- Sponsor
- Lumos Diagnostics
Coccidioidomycosis, Disseminated Fungal Infection
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
The purpose of this study is to test measurement tools (questionnaire about symptoms and a questionnaire about quality of life) to assess usability in the assessment of treatment effectiveness for people with disseminated…
- Conditions
- Coccidioidomycosis, Disseminated Fungal Infection, Coccidioides Infection, Coccidioides Immitis Infection
- Trial name
- COCCIMETRICS (NCT07712484)
- Testing
- Olorofim
- Volunteers
- 50 people
- Sponsor
- F2G Ltd
Cirrhosis, Liver, Hepatic Cirrhosis
HCCBloodTest for Detection of Hepatocellular Carcinoma (HCC)
This is a multi-center study to prospectively gather clinically-characterized plasma samples to determine the diagnostic performance characteristics (sensitivity and specificity) of the HCCBloodTest among patients with cirrhosis…
- Conditions
- Cirrhosis, Liver, Hepatic Cirrhosis, Hepatocellular Carcinoma, Liver Cancer
- Trial name
- NCT03804593
- Where
- 2 sites in United States
- Volunteers
- 175 people
- Sponsor
- Epigenomics, Inc
Sepsis, Septic Shock
Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study
The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic…
- Trial name
- SYMON II (NCT06654895)
- Where
- 5 sites in United States
- Volunteers
- 700 people
- Sponsor
- Bluejay Diagnostics, Inc.
Spinal Muscular Atrophy
A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular Disorders
The primary objective of the study is to explore the convergent validity of smartphone-based Konectom DOAs against in-clinic standard assessments.
- Trial name
- DigiNOA (NCT05109637)
- Testing
- Konectom NMD Application
- Where
- 5 sites in Germany
- Volunteers
- 93 people
- Sponsor
- Biogen
Atrial Fibrillation
Withings ECG-Monitor Study
The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation
- Trial name
- NCT05316337
- Testing
- Electrocardiogram recording
- Where
- 10 sites in United States, France
- Volunteers
- 650 people
- Sponsor
- Withings