Clinical trials: Validation Studies
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
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
Blood Pressure Monitoring, Blood Pressure
Noninvasive Blood Pressure Validation Study
The purpose of this study is to test how accurately the Perin Health Patch, a small wearable sensor worn on the chest, measures blood pressure without using an arm cuff.
- Trial name
- NCT07774169
- Testing
- Chest Worn Blood Pressure Monitor
- Where
- United States
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
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
Health Volunteer Validation Study
Vital Signs Validation Study of the μ-Cor System (ViVUS Validation)
This study has the following objective: To validate the capability of the μ-Cor System to monitor ECG, Heart Rate (HR), Respiration Rate (RR), Posture and Activity in healthy human subjects.
- Trial name
- ViVUS (NCT02975050)
- Testing
- Location
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zoll Medical Corporation
Delayed Union Fracture, CT-scan
A mRUS Validation Study for Nail-treated Fractures of Long Bones and a TUS Exploratory Study for Nail and Plate-treated Fractures of Long Bones
Early intervention attempts to shorten protracted delayed union (DU) or prevent non-union (NU) fractures are hampered by lack of validated quantitative assessment tools for bone fracture healing during normal and delayed healing…
- Conditions
- Delayed Union Fracture, CT-scan, X-Ray, Bone Fracture
- Trial name
- mRUSTUS (NCT03286270)
- Where
- 4 sites in Germany
- Volunteers
- 173 people
- Sponsor
- Bone Therapeutics S.A
Healthy Subjects, Chronic Conditions, Multiple
Heart Rate and Respiratory Rate Measurements by a Novel, Radar-based Device
A single center, single blinded, prospective validation (including extension0 study for the accuracy and safety evaluation of Neteera 130H, a novel, radar-based contact-free device for heart and respiratory rate measurements.
- Trial name
- NCT04796181
- Testing
- Neteera 130H
- Where
- 2 sites in United States, Israel
- Volunteers
- 170 people, healthy volunteers welcome
- Sponsor
- Neteera Technologies Ltd.
To Assess Cardiovascular Function
QuantaFlo HD Clinical Validation Study
The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration…
- Trial name
- NCT07219693
- Testing
- QuantaFlo HD
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Semler Scientific
Type 2 Diabetes, Diabetes (DM)
Detecting Type 2 Diabetes From Voice
The goal of this observational study is to learn if computer analysis of voice recordings can detect Type 2 diabetes in adults. The main questions it aims to answer are: Can advanced voice analysis accurately identify…
- Conditions
- Type 2 Diabetes, Diabetes (DM), T2DM, T2DM (Type 2 Diabetes Mellitus)
- Trial name
- NCT07421921
- Where
- United Kingdom
- Volunteers
- 7,319 people, healthy volunteers welcome
- Sponsor
- Thymia Limited
Preventive Care
Evaluation of the Sub Epidermal Moisture a Device for the Screening of Pressure Ulcer (RELIASEM)
The device that is the subject of this investigation is a diagnostic tool to detect the among of fluid in hypodermis to help to prevent the formation of pressure injuries.
- Trial name
- RELIASEM (NCT04955106)
- Testing
- SEM Scanner
- Where
- France
- Volunteers
- 52 people
- Sponsor
- Arjo France
Covid19
Saliva-based COVID-19 DNA Aptamer Test
This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit…
- Trial name
- NCT04974203
- Testing
- AptameX
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- Achiko AG
Total Aortic Arch Replacement
Near-Infrared Spectroscopy Comparison Study
The objective of this study is to validate Near-Infrared (NIRS) monitoring in patients undergoing circulatory arrest. This study will compare two-wavelength NIRS INVOS System, Somanetics; Troy, MI) with four-wavelength NIRS…
- Trial name
- NCT01352260
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Nonin Medical, Inc
Atrial Fibrillation
Electrocardiogram Clinical Validation Study
The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer…
- Trial name
- NCT04842123
- Testing
- Electrocardiogram
- Where
- 6 sites in United States
- Volunteers
- 568 people, healthy volunteers welcome
- Sponsor
- Garmin International
Refractive Errors, Astigmatism
Study of a Hand-held Device Plus Mobile App Versus Standard Eye Care Devices in Measuring Refractive Error of the Eye
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
- Trial name
- NCT03929588
- Testing
- Hand-held device supported by a mobile application, Phoropter, Autorefractor
- Where
- United States
- Volunteers
- 230 people, healthy volunteers welcome
- Sponsor
- EyeQue Corp.
PULSE OXIMETRY
SPO2 VALIDATION STUDY - PHILIPS FAST 2025
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.
- Trial name
- NCT07221526
- Testing
- NO INTERVENTION
- Where
- United States
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Osteoarthritis, Knee
A Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension
The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed.
- Trial name
- NCT05539326
- Testing
- Performance Clinical Outcome Test
- Where
- 6 sites in United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Canary Medical
Atrial Fibrillation
Validation Study of Frontier X Plus (FX+) Device
The main objective of this study is to validate the specificity and sensitivity of FX+ detecting atrial fibrillation (AF) in both AF and non-AF subjects using a comparative approach, which involves using both a US FDA-cleared…
- Trial name
- NCT06471764
- Testing
- FX+ and 12-Lead ECG Recording
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Fourth Frontier Technologies Pvt Ltd.
Pregnant Women
Sleep Position Pattern Recording
The main goal of this study is to validate the accuracy of the body position detection by non-invasive wearable monitors (Skiin garments, Myant Medical Corp) during sleep in pregnant participants.
- Trial name
- NCT06286904
- Testing
- Skiin Garment system
- Where
- Canada
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Myant Medical Corp.
QTc Evaluation, Electrocardiography
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
The aim of this study is to investigate the effect of moxifloxacin on the QT interval in order to gain information on the validity of results that will be collected during another clinical study testing riociguat in patients with…
- Trial name
- NCT01014247
- Testing
- Avelox (Moxifloxacin, BAY12-8039)
- Where
- 6 sites in Australia, Germany and 2 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Bayer
Prostate Cancer
Prospective Validation of Prostate Biomarkers for Repeat Biopsy
Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy scheduled for repeat biopsy. Subjects must have had their negative index prostate biopsy procedure within 30 months of being scheduled for…
- Trial name
- PRIORITY (NCT03082274)
- Testing
- ConfirmMDx, SelectMDx
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- MDx Health