Clinical trials: Validation Studies
- Condition Validation Studies
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Psychological Well Being
Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study
This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine…
- Trial name
- WB6Dim-TRT (NCT07433764)
- Where
- France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Clover Link
Pain, Inflammation
UVB Model Validation Study
Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy…
- Conditions
- Pain, Inflammation, Healthy Volunteers
- Trial name
- NCT01055249
- Testing
- Ibuprofen, Hydrocortisone, Hydrocortisone
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- X-pert Med GmbH
Obstructive Sleep Apnea
TipTraQ Home Sleep Test Validation Study, VGH
A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional…
- Trial name
- NCT06474390
- Where
- Taiwan
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Alzheimer Disease, Dementia
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's Disease
This is a 24-month, monocentric, exploratory and observational clinical study aimed at developing and validating a blood-based diagnostic test for Alzheimer's disease (AD).
- Conditions
- Alzheimer Disease, Dementia, Neurodegenerative Disorders, Cognitive Decline
- Trial name
- ADKIT (NCT07294586)
- Where
- France
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Amoneta Diagnostics SAS
Eye Disease
iCam Clinical Validation Study
Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.
- Trial name
- NCT01600261
- Where
- 2 sites in United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Optovue
Hypoxia
RDS MultiSense® SpO2 Validation Study
The purpose of this clinical study is to validate the oxygen saturation (SpO2) accuracy of the RDS MultiSense® Pulse Oximetry during non-motion conditions over the range of 70-100% arterial oxygen saturation (SaO2) as compared to…
- Trial name
- NCT05359328
- Testing
- Pulse Oximeter, Respiratory Rate, Heart Rate and Arterial line
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rhythm Diagnostic Systems
Sleep Apnea
A Validation Study of the NightOwl 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
- NCT04764734
- Testing
- NightOwl
- Where
- 4 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
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
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Cervical Cytology, PAP
Techcyte SureView Cervical Cytology System Clinical Validation Study
The clinical study is a multi-center, retrospective, blinded, matched-pair, two-arm clinical study in which one test assessment and a control assessment of liquid-based cytology (LBC) pap tests are performed and compared to a…
- Trial name
- NCT06767111
- Testing
- Digital cervical cytology slide imaging system with artificial intelligence (AI) algorithm in vitro diagnostic (IVD) device
- Where
- United States
- Volunteers
- 4,596 people, healthy volunteers welcome
- Sponsor
- Techcyte, Inc.
Cognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children
Parent-Child EF Intervention
Koronis Biomedical Technologies Corporation (KBT) is developing a cognitive intervention to promote healthy development of Executive Function (EF) skills in young children by leveraging a smartphone-based training regime designed…
- Trial name
- NCT06924307
- Testing
- Executive Function Intervention
- Where
- 2 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Koronis Biomedical Technologies
Multiple Sclerosis
Validation of DigiCog and Konectom Tools to Support Digitalized Clinical Assessment in Multiple Sclerosis
The primary objective of this study is to establish scores of Cognitive impairment (CI) of the 3 DigiCog [Brief Computerized Cognitive Assessment for Multiple Sclerosis (BCCAMS) app] tests [Computerized Speed Cognitive Test…
- Trial name
- DigiToms (NCT04756700)
- Testing
- DigiCog (BCCAMS app), Konectom Application
- Where
- France
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Biogen
Prenatal Diagnosis, Genetics
Identifai Genetics Analytic Validity Study - Compound Heterozygosity and Samples Collection
The purpose of this study is to validate a noninvasive prenatal diagnosis procedure for genetic conditions in the developing fetus by analyzing fetal genetic material present in the pregnant mother's blood.
- Trial name
- NCT06239077
- Testing
- Non Invasive Prenatal Test via blood sample
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Identifai Genetics
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
Depressive Disorder, Major
Study to Evaluate the Performance Validity and Test-Retest Reliability of a Computer-Administered Cognitive Test Battery in Participants With Major Depressive Disorder (MDD)
The purpose of this study is to examine concurrent validity of 8 computerized tests intended for the assessment of cognitive function in participants with Major Depressive Disorder (MDD), relative to 8 corresponding and…
- Trial name
- NCT03014544
- Testing
- Computer- administered test battery, Examiner- administered test battery
- Where
- 20 sites in United States
- Volunteers
- 585 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Sleep Apnea
Validation of Software for Assessment of Sleep Apnea From Data Acquired by a Wearable Smartwatch
This clinical validation study aims to evaluate the utility of Fitbit's Sleep Apnea Alert software for minimally invasive monitoring of sleep apnea events to alert users of their risk of sleep apnea.
- Trial name
- NCT03775291
- Testing
- Simultaneous assessment of sleep apnea by polysomnogram and wearable device
- Where
- 6 sites in United States, Ireland
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
NAFLD, NASH - Nonalcoholic Steatohepatitis
Development and Validation of a Multi-target, Blood-based NAFLD Diagnosis Test
Multi-omics approach was used to identify patterns of serological biomarkers to diagnose NAFLD. The purpose of this study is to develop and validate a blood-based assay to diagnose NAFLD by collecting blood sample from healthy…
- Trial name
- NCT05108415
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Pancreatic Cancer Stage I, Pancreatic Cancer Stage II
Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
This is a case-control study to clinically validate the performance of a protein biomarker test to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control…
- Conditions
- Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis, PDAC - Pancreatic Ductal Adenocarcinoma
- Trial name
- CLARITI (NCT06947382)
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 1,066 people, healthy volunteers welcome
- Sponsor
- Immunovia, Inc.
Gastroparesis
ABCA2 GIRMS Analytical Validation Clinical Performance Study
The purpose of this study is to collect human breath samples for use in a validation study intended to demonstrate equivalent clinical performance measures of new ABCA2 GIRMS (Automated Breath Carbon Analyzer-2 Gas Isotope Ratio…
- Trial name
- NCT04607304
- Testing
- ABCA2 GIRMS
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Cairn Diagnostics
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