Clinical trials: Validation Studies
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
Diabetes Mellitus
Validation Study of G4 User Interface
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.
- Trial name
- G4 (NCT01142895)
- Volunteers
- 33 people
- Sponsor
- Tandem Diabetes Care, Inc.
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
Heart Failure
Prospective Study With AMI Patients Undergoing PCI
CardioSAVE is a prospective 12-month controlled longitudinal study for the validation of a novel predictive model and a diagnostic tool, for the risk stratification of AMI patients undergoing PCI, with a one year follow-up.
- Trial name
- CardioSAVE (NCT03038360)
- Where
- Germany
- Volunteers
- 620 people
- Sponsor
- Firalis SA
Bone Metastasis
Bone Pain Score Validation Initiative
Translation and validation of the BOMET-QoL-10 questionnaire in Germany and assessment of its validity and responsiveness.
- Trial name
- ARIE (NCT02293642)
- Where
- Germany
- Volunteers
- 370 people
- Sponsor
- iOMEDICO AG
Kidney Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Atrial Fibrillation (AF), Atrial Fibrillation New Onset
Clinical Validation of SMD-AFECG for Predicting New-Onset Atrial Fibrillation Within 2 Hours Using Single-Lead ECG Data
The purpose of this retrospective study is to evaluate the clinical performance of SMD-AFECG, an artificial intelligence-based medical device software that predicts the risk of atrial fibrillation occurring within 2 hours using…
- Trial name
- NCT07722078
- Volunteers
- 797 people
- Sponsor
- HUINNO Co., Ltd
Mild Cognitive Impairment, Alzheimer's Disease
A Validation Study of the Novel Application of Telehealth in Clinical Drug Development in Subjects With Mild Cognitive Deficits
REINVENT is a non-interventional, multi-center, research network-based cross-over study evaluating the potential utility of a telehealth platform in improving the efficiency of clinical trials.
- Trial name
- REINVENT (NCT02778438)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Quintiles, Inc.
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
Diagnostic Techniques and Procedures, Clinical Laboratory Techniques
Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
- Conditions
- Diagnostic Techniques and Procedures, Clinical Laboratory Techniques, Triage
- Trial name
- LTC-VALID (NCT07810491)
- Testing
- AI-based laboratory result interpretation software
- Where
- 2 sites in Poland
- Volunteers
- 899 people
- Sponsor
- Labplus Sp. z o.o.
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
Cervical Spinal Cord Injury
ExaStim Upper Limb Home Use Clinical Validation Study
This is a multi-center, observational, single-arm, 6-week home study to evaluate the safety and efficacy of transcutaneous spinal cord stimulation via the ExaStim system for 4 consecutive weeks used in the home setting for…
- Trial name
- NCT06850363
- Testing
- ExaStim Stimulation System
- Where
- 5 sites in United States
- Volunteers
- 33 people
- Sponsor
- Niche Biomedical, Inc. dba ANEUVO
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