Clinical trials: Validation Studies
Obesity
Signature Diagnostic of Non-alcoholic Steatohepatitis (NASH) by Infrared Light Spectroscopy
Evaluation of the diagnostic performance of an algorithm developed to detect metabolic profiles specific of non-alcoholic steatohepatitis NASH and based on the reading of a blood sample's infrared spectra
- Trial name
- SIGNALS (NCT03978247)
- Testing
- NASHMIR
- Where
- Belgium
- Volunteers
- 382 people
- Sponsor
- Diafir
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.
Cardiopulmonary
Observational, Non-Interventional Study Supporting Validation of eVO2peak Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
In this study, the hypothesis being explored is that peak VO2 and potentially other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected…
- Trial name
- NCT05678530
- Where
- 16 sites in United States, Canada
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Prolaio
Cancer, Predictive Cancer Model
KM3D Multicenter Cancer Consortium: Predicting Patient Response Using 3D Cell Culture Models
This study will assess the ability of the Known Medicine platform to predict the efficacy of certain cancer drug treatments and to validate that tumor organoid drug sensitivity is representative of patient treatment outcomes.
- Conditions
- Cancer, Predictive Cancer Model, Effects of Chemotherapy
- Trial name
- NCT05338073
- Testing
- Known 3Dx Test
- Where
- 3 sites in United States
- Volunteers
- 2,000 people
- Sponsor
- Known Medicine, Inc.
Heart Failure, Kidney Disease
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
The study has two objectives based on the intended-use measurements and populations described above. The first objective is to show that relative changes in impedance as measured by the test device (ΔSFI) are strongly correlated…
- Trial name
- NCT02140905
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- Baxter Healthcare Corporation
Infertility
Eeva System Imaging Study
The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.
- Trial name
- PROSPECT (NCT02301637)
- Testing
- Eeva™ Test
- Where
- 7 sites in United States, New Zealand
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Progyny, Inc.
Renal Insufficiency, Chronic, Heart Failure
Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are: 1.To evaluate the performance of S-There Device in comparison to the…
- Conditions
- Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus, Diabetes; Nephropathy (Manifestation)
- Trial name
- STSD-2019-001 (NCT03965975)
- Testing
- Lab Gold Standard, S-There
- Where
- Spain
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- S-There Technologies SL
Pre-surgical Anxiety, Blood Glucose Concentration
Vis Pre Surgery Medical Food Validation Study
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications…
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels
- Trial name
- NCT07359222
- Testing
- Pre-surgical medical food
- Where
- India
- Volunteers
- 67 people
- Sponsor
- TM Nutrition LLC
COVID-19
Detection of COVID-19 Using Breath Analysis - Validation Study.
Detection of the 2019 novel Coronavirus (SARS-CoV-2) using breath analysis - Validation study.
- Trial name
- NCT05224622
- Testing
- VOX
- Where
- Israel
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Scentech Medical Technologies Ltd
Healthy Female Volunteers
Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation
This research is being carried out in order to compare two alternative versions of the Neurotech Vital Devices which have been set up to provide two different types of stimulation.
- Trial name
- NCT01632748
- Testing
- Neurotech Vital Device, Modified Neurotech Vital Device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Bio-Medical Research, Ltd.
Normal and Ocular Pathology
Clinical Validation Study for iVue
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.
- Trial name
- NCT01242553
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Optovue
COPD, Healthy Volunteers
Airvo 3 Respiratory Rate Validation Study
This is a clinical performance testing to validate the accuracy of the Airvo 3 device with respiratory rate algorithm manufactured by Fisher \& Paykel Healthcare for continuous respiratory rate monitoring.
- Trial name
- NCT06329609
- Testing
- Airvo 3 with respiratory rate algorithm
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Atrial Fibrillation
Fibricheck Detection cApabilities for Atrial Fibrillation
Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.
- Trial name
- FDA-AF (NCT06282380)
- Testing
- FibriCheck Mobile Application
- Where
- 5 sites in United States, Belgium
- Volunteers
- 330 people
- Sponsor
- Qompium NV
Coronary Artery Disease, Stable Angina
Validation of the MedHub AutocathFFR Software Device for Non-Invasive Fractional Flow Reserve (FFR)
This observational study evaluated how well the AutocathFFR software measures fractional flow reserve (FFR) from coronary angiogram images.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, Non-ST-Elevation Myocardial Infarction
- Trial name
- NCT07763769
- Testing
- MedHub AutocathFFR
- Where
- 4 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medhub Ltd.
BCL2 Gene mRNA Overexpression
Validation of Useful Markers Generated by Next Generation Bio-data Based Genome Research and Cohort Study
Multiple biomarker development through validation of useful markers generated by next generation bio-data based genome research and cohort study
- Trial name
- miRNA_Chip (NCT02807896)
- Where
- South Korea
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- CHANGHEE LEE
Cardiovascular Autonomic Neuropathy
Clinical Validation of a Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System
This is a open-label, randomized, paired design, multicenter study of the Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (R6000) for evaluating cardiovascular autonomic neuropathy.
- Trial name
- CARTS (NCT06447896)
- Testing
- Cardiovascular Autonomic Nervous Function Multi-Parameter Evaluation System (Model: R6000), Conventional method of CARTs, Ambulatory holter station Model i12 plus
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- REEM (Shenzhen) Healthcare Co., Ltd
Pulse Oximetry
NEXT GEN - PHILIPS OPTIMUS
The purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
- Trial name
- NCT07521735
- Testing
- Philips MR400 Pro MRI Patient Monitor
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Hemiplegia
Atalante USAbility
The "USAbility" study - Human Factor Validation Testing of the Atalante exoskeleton aims at demonstrating that Atalante can be used by the intended users without serious use errors or problems, for the intended uses and under the…
- Trial name
- NCT05284708
- Testing
- Atalante
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wandercraft
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
Contraception
Validation of Effectiveness on NaturalCycles Users
The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility.
- Trial name
- VENUS (NCT07566793)
- Testing
- Log daily intercourse information, Natural Cycles application
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Natural Cycles