Clinical trials: Validation Studies
Ultrasound Imaging of Anatomical Structures
A Volunteer Study to Collect Imaging Data for the Development and Validation of ScanNav Anatomy PNB
This is a single-centre, prospective, non-randomised volunteer study to be undertaken in Intelligent Ultrasound's offices at Hodge House, 114-116 St Mary Street, Cardiff, CF10 1DY, UK.
- Trial name
- NCT04830891
- Where
- United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- IntelligentUltrasound Limited
Allergic Asthma, Allergy
Validation of Strasbourg Environmental Exposure Chamber ALYATEC in Cat Allergic Subjects With Asthma
This is a randomized, double blind, cross-over study designed to determine the concentration of airborne cat allergen inducing bronchial response in asthmatic subjects allergic to cat, during allergen exposures in the Alyatec…
- Conditions
- Allergic Asthma, Allergy, Allergy to Cats
- Trial name
- NCT04678063
- Testing
- Exposure to dose A and dose B of cat allergen, Exposure to a single dose of cat allergen
- Where
- France
- Volunteers
- 31 people
- Sponsor
- Alyatec
Pathological Processes
This Study is the Clinical Validation Study for Validation for the Digital Pathology System 'SGi 1.0 + EPW 1.0 + Compatible Clinical Displays'
The primary objective of this study is to show safety and effectiveness of the investigational device for In Vitro Diagnostic (IVD) use as an aid to the pathologist to view, review and diagnose digital images of surgical…
- Trial name
- NCT07881874
- Testing
- Digital pathology system
- Where
- 2 sites in United States
- Volunteers
- 470 people
- Sponsor
- Philips Digital & Computational Pathology
Retinitis Pigmentosa, Retinal Dystrophy
Observational Study to Assess the Reliability and Validity of the MLYMT and MLSDT
This is a prospective Multi-Center Observational Study to assess the reliability and validity of the Multi-Luminance Y-Mobility Test (MLYMT) and Multi-Luminance Shape Discrimination Study (MLSDT) Main Outcome Measures: (i)…
- Trial name
- NCT05820100
- Testing
- Observational
- Where
- 8 sites in United States, Puerto Rico
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Nanoscope Therapeutics Inc.
Laparoscopic Gynecological Surgical Procedures
Clinical Validation Study of the Eximis CS (Contained Segmentation) System
The purpose of this study is to evaluate device safety and effectiveness of the Eximis CS System.
- Trial name
- NCT06572163
- Testing
- Eximis CS (Contained Segmentation) System
- Where
- 4 sites in United States
- Volunteers
- 23 people
- Sponsor
- Eximis Surgical
Validation Study
The Sunrise SpO2 and Pulse Rate Accuracy Validation Study
The purpose of this study is to evaluate the SpO2 accuracy performance of the Sunrise Sensor 2 placed at the tip of the chin during non-motion conditions over the range of 70-100% by comparison to SaO2 values determined from…
- Trial name
- S2-SOPRAV (NCT05386836)
- Testing
- Pulse oximeter validation population
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Sunrise
Pelvic Organ Prolapse
Validation of Transvaginal Tactile Imaging
The purpose of this study is to validate safety and effectiveness in assessment of the female pelvic floor tissue, and, assess the ability of Vaginal Tactile Imager (VTI) to detect early prolapse conditions and characterize the…
- Trial name
- VTI-03 (NCT01491334)
- Where
- 2 sites in United States
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Artann Laboratories
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
Precise Image (AI Reconstruction Feature of CT 5400 RT System)
Clinical Study of CT 5400 RT for Precise Image Validation
The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System
- Trial name
- NCT06589934
- Testing
- Precise Image
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Mycobacterium Infections, Nontuberculous
Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the…
- Trial name
- ARISE (NCT04677543)
- Testing
- ALIS, Azithromycin, Ethambutol
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 99 people
- Sponsor
- Insmed Incorporated
Lung Cancer
Determination and Validation of a Multi-analyte Assay for Lung Cancer Screening
This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.
- Trial name
- NCT04968548
- Testing
- Blood collection
- Where
- 31 sites in United States, Canada
- Volunteers
- 6,182 people
- Sponsor
- Nucleix Ltd.
Hypertension
Withings Hypertension Notification Retrospective Study
This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic…
- Trial name
- HTNF (NCT07631715)
- Testing
- Withings Blood Pressure Monitor (reference), Withings Hypertension Notification Feature (HTNF)
- Where
- France
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- Withings
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
Genetic Health Risks
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro-diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders.
- Trial name
- ApoDiag (NCT06432192)
- Testing
- APO-Easy
- Where
- 2 sites in France
- Volunteers
- 1,474 people, healthy volunteers welcome
- Sponsor
- Firalis SA
Cancer, Breast, Triple Negative Breast Cancer
VISION: Triple Negative Breast Cancer Sample and Clinical Data Acquisition Study
Background: Despite improvements in the treatment of Triple Negative Breast Cancer (TNBC), the cancer returns in half of the women and shockingly 40% are dead within 5 years of their initial cancer diagnosis.
- Conditions
- Cancer, Breast, Triple Negative Breast Cancer, Early-stage Breast Cancer
- Trial name
- NCT06409221
- Testing
- Non-interventional study, Observational only
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Concr
Oxygen Deficiency
Validation of the O3 Regional Somatic Tissue Oxygenation Monitor
Testing the absolute accuracy of the Masimo O3 regional oximeter in reading somatic tissue oxygenation in healthy volunteers under controlled hypoxia.
- Trial name
- NCT04584788
- Testing
- Masimo O3 Regional Oximeter
- Where
- Netherlands
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Masimo 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
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
Opioid-Related Disorders, Opiate Addiction
A Quantitative Study to Assess the Construct Validity of the Prescription Opioid Misuse and Abuse Questionnaire
The purposes of this study are to evaluate the validity and reproducibility of the POMAQ to identify opioid abuse and misuse behaviors among participants who have chronic pain which requires long-term opioid use.
- Conditions
- Opioid-Related Disorders, Opiate Addiction, Narcotic Abuse, Drug Abuse
- Trial name
- POMAQ (NCT02678507)
- Testing
- Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)
- Volunteers
- 800 people
- Sponsor
- Member Companies of the Opioid PMR Consortium
Pulmonary Disease, Chronic Obstructive, Infections, Bacterial
Observational Study Of An Electronic Questionnaire In Patients With Chronic Obstructive Pulmonary Disease (COPD)
The aim of the study is to develop a new patient-reported outcome (PRO) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT00259909
- Testing
- GSK questionnaire, St. George's Respiratory Questionnaire, Acute Short Form 12 version 2
- Where
- 123 sites in United States, Germany and 1 more
- Volunteers
- 259 people
- Sponsor
- GlaxoSmithKline