Clinical trials: Validation Studies
Covid19
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
- COVID-19 (NCT04602949)
- Testing
- Breath Biopsy Analysis
- Where
- Israel
- Volunteers
- 2,558 people, healthy volunteers welcome
- Sponsor
- Scentech Medical Technologies Ltd
Hypoxia, Desaturation of Blood
SpO2 Accuracy Validation of the OxySoft Sensor Via Reference CO-Oximetry Motion Study
SpO2 (oxygen saturation) and pulse rate accuracy of pulse oximetry equipment, OxySoft Sensor/N-600x and OxySoft Sensor/N-395, continuous measure of arterial oxygen saturation during hypoxic state throughout motion and non-motion…
- Trial name
- NCT04559763
- Testing
- Non-Invasive Controlled Hypoxia, Introduction of Motion conditions: tapping or rubbing
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Aging, Aging Well
100-Year Human Aging Study
The 100-Year Human Aging Study is a prospective, pragmatic, observational trial enrolling participants across fixed clinical sites, mobile clinical sites, and an online participation pathway (current and future) to undergo…
- Conditions
- Aging, Aging Well, All-Cause Mortality, Mortality
- Trial name
- NCT07563777
- Testing
- Comprehensive Multi-System Clinical Screening
- Where
- United States
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Longevity Metrics, Inc.
Adnexal Mass, Ovarian Cancer
Clinical Validation of the InterVenn Ovarian CAncer Liquid Biopsy
Venn Biosciences Corporation ("InterVenn") has developed a liquid biopsy that is capable of distinguishing benign from malignant masses in women presenting with adnexal (pelvic) masses, through a simple blood test.
- Conditions
- Adnexal Mass, Ovarian Cancer, Pelvic Mass
- Trial name
- VOCAL (NCT03837327)
- Where
- 26 sites in United States, Australia and 2 more
- Volunteers
- 1,025 people
- Sponsor
- Venn Biosciences Corporation
Heart Failure, Congestive
Evaluation of MRI Measures of Lung Water With Posture Changes in Healthy Volunteers and in Patients With Cardiac Failure
The aim of this study is to establish a model for the evaluation of drug targets using postural measures to induce changes in lung water concentration as assessed by MRI.
- Trial name
- NCT01277679
- Testing
- MRI
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Non-melanoma Skin Cancer
DERM NMSC Validation Study
This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign…
- Trial name
- NCT04116983
- Testing
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Where
- 3 sites in United Kingdom
- Volunteers
- 572 people
- Sponsor
- Skin Analytics Limited
Shortness of Breath
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
The purpose of this study is to assess the efficacy of Caption LungAI.
- Trial name
- NCT05992324
- Testing
- Caption LungAI
- Where
- 4 sites in United States
- Volunteers
- 220 people
- Sponsor
- Caption Health, Inc.
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
Alzheimer's Disease
A Retrospective Database Study for the Development and Validation of Algorithms for Intracerebral Hemorrhage and Seizures in Alzheimer's Disease
The primary objective of this study is to develop and validate claims-based algorithms to identify intracerebral hemorrhage >1 cm in diameter, ensuring differentiation from amyloid-related imaging abnormality-microhemorrhage and…
- Trial name
- NCT07723950
- Testing
- No intervention
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Eisai Inc.
Burns, Wound Heal
Burn Validation Study
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
- Conditions
- Burns, Wound Heal, Wounds and Injuries
- Trial name
- BVS (NCT06131203)
- Testing
- DeepView SnapShot Portable (DV-SSP)
- Where
- 21 sites in United States
- Volunteers
- 274 people
- Sponsor
- SpectralMD
Sleep Apnea, Obstructive
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.
- Trial name
- NCT01943708
- Testing
- SPAP, CPAP
- Where
- New Zealand
- Volunteers
- 74 people
- Sponsor
- Fisher and Paykel Healthcare
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
Cardiovascular Diseases, Hypertension
Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of…
- Trial name
- eXPLORE (NCT05580068)
- Testing
- Hypertension therapy through iATROS medical device
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- iATROS GmbH
ECG, Electrocardiography
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older.
- Conditions
- ECG, Electrocardiography, Monitoring, Physiologic
- Trial name
- NCT07147920
- Testing
- Chest-Worn ECG Monitoring Device
- Where
- United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
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.
Major Depressive Disorder, Bipolar I and Bipolar II
Bipolar Proteomic Assay Validation Study
The purpose of this study is to validate a set of signatures, based on a panel of proteomic markers, that discriminate BDI, BDII, and MDD in people seeking treatment for a depressive episode.
- Trial name
- NCT02746367
- Testing
- Diagnostic test (LDT)
- Where
- 5 sites in United States
- Volunteers
- 261 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
Suicidality
A Study to Assess the Validation and Mapping of the Suicide Ideation and Behavior Assessment
The main purpose of this cross-sectional study is to generate data to support the psychometric properties of the Suicide Ideation and Behavior Assessment Tool (SIBAT) and validate its use in participants at imminent risk of…
- Trial name
- NCT03085108
- Testing
- No Intervention
- Where
- 4 sites in United States
- Volunteers
- 130 people
- Sponsor
- Janssen Scientific Affairs, LLC
Laparoscopic Gynecological Surgery
Human Factors Actual-Use Clinical Protocol
The purpose of this study is to confirm device use safety and effectiveness of the Eximis CS (Contained Segmentation) System in actual use by representative users, use, and use environments as required for regulatory agency…
- Trial name
- CONTAIN (NCT04799210)
- Testing
- Eximis CS (Contained Segmentation) System
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Eximis Surgical
Retinopathy of Prematurity, ROP
Automated Screening Device to Detect MTMROP
The purpose of the study is to evaluate the i-ROP DL system for autonomous ROP screening. To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by healthcare providers in the neonatal intensive…
- Trial name
- NCT06517836
- Testing
- iROP DL
- Where
- United States
- Volunteers
- 1,284 people, healthy volunteers welcome
- Sponsor
- Siloam Vision