Clinical trials: System Validation
- Condition System Validation
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
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
Colorectal Cancer
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"
The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.
- Trial name
- NCT04144738
- Testing
- mt-sDNA 2.0 screening test, FIT test, Colonoscopy
- Where
- 195 sites in United States
- Volunteers
- 26,758 people, healthy volunteers welcome
- Sponsor
- Exact Sciences Corporation
Breast Cancer
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography.
- Trial name
- NCT00756834
- Testing
- Screening
- Where
- United States
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions
Allergy, Immunoglobulin E-Mediated Allergic Disorder
Kenota 1 CWS Method Comparison Validation Study
The goal of this Method Comparison Study is to compare total IgE results obtained from at least 360 subjects aged less than 80 years old using four different testing arms comprising three types of samples and two testing methods.
- Trial name
- NCT05702671
- Testing
- Total Immunoglobulin E, Obtained From Fingerstick Sample
- Where
- 3 sites in United States
- Volunteers
- 411 people, healthy volunteers welcome
- Sponsor
- Kenota Inc.
Vaping, Underage
Human Factors Validation and Usability Testing of the IKE Age-Gating System
A multi-center human factors validation study to demonstrate the function of the IKE Bluetooth system on a chip (SoC) and mobile applications ability to age-gate a device, accurately identify an individuals age, race/ethnicity…
- Trial name
- NCT06952569
- Testing
- IKE System
- Where
- 4 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- IKE Tech
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
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.
Colo-rectal Cancer, Cancer Colon
AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test
Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early.
- Conditions
- Colo-rectal Cancer, Cancer Colon, Cancer, Rectum, Neoplasms,Colorectal
- Trial name
- NCT03688906
- Where
- 30 sites in United States, Canada
- Volunteers
- 3,275 people, healthy volunteers welcome
- Sponsor
- Freenome Holdings Inc.
T1D
Validation of a Computerised Adaptive Test for Measuring Caregiver Well-being
The main objective of this project is to test whether a tool (questionnaire) is suitable for assessing how caregivers of children and adolescents with TD1 feel emotionally and psychologically.
- Trial name
- NCT06999486
- Testing
- CAT well-being test
- Where
- Spain
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Adhera Health, Inc.
Thoracic Cancer, Ovarian Cancer
Project CADENCE (CAncer Detected Early caN be CurEd)
With existing evidence showing the difference in miRNA expression levels between non-cancer and cancer groups, the investigators assume that levels of DNA methylation, RNA expression as well as protein concentration will also be…
- Conditions
- Thoracic Cancer, Ovarian Cancer, Liver Cancer, Prostate Cancer
- Trial name
- CADENCE (NCT05633342)
- Where
- Singapore
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- MiRXES Pte Ltd
Dementia, Mild Cognitive Impairment
HOme-based Brain Monitoring With a GARment-EEG to Study Cognitive Decline in the Aging Population
This study will investigate the validity of the HOGAR EEG/PSG monitoring kit designed by Bitbrain as a tool for characterizing and assessing cognitive function in older adults, as well as for detecting and predicting cognitive…
- Conditions
- Dementia, Mild Cognitive Impairment, Dementia Alzheimers, Dementia, Mixed
- Trial name
- Hogar (NCT06993207)
- Testing
- Home Lab
- Where
- Spain
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Bitbrain
Dementia, Pain
PainChek® US Validation Nursing Home Study
Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities.
- Trial name
- NCT06049732
- Testing
- PainChek®
- Where
- 5 sites in United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- PainChek Ltd
Asthma
Validation of Structured Light Plethysmography: Asthma
Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in…
- Trial name
- SLPBD (NCT02543333)
- Where
- 2 sites in United Kingdom
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- Pneumacare Ltd
Body Temperature, Febrile
Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System
Moni-Patch Temperature Monitoring Patch System, a non-invasive, continuous temperature monitoring device designed to estimate core body temperature by applying a Sensor to the neck.
- Trial name
- NCT07397078
- Testing
- Moni-Patch Temperature Monitoring Patch System
- Where
- United States
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- Murata Vios, Inc.
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
Sleep Disorder, Nightmare
Validation of the Sleep Assessment Algorithm in the Medical Application Nightly
The Nightly medical application prototype is a potential, non-invasive class I medical device. The application has the potential to combine both diagnostic and therapeutic procedures for sleep.
- Trial name
- NCT03532269
- Testing
- Nightly App
- Where
- Poland
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- DreamJay Sp. z o. o.
Diabetes Mellitus, Type 2, Liver Diseases
Validate Smart Breath Analyzer as Screening Tool for Diabetic, Hepatic, Renal, Lung, and Other Metabolic Disorders
This is a prospective, multicentric, non-treatment study to build and validate a portable, non-invasive smart breath analyzer that can screen underlying health issues using exhaled breath.
- Conditions
- Diabetes Mellitus, Type 2, Liver Diseases, Kidney Diseases, Lung Diseases
- Trial name
- RESPYR-SBA (NCT07646015)
- Where
- India
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Respyr
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
Sleep Apnea, Obstructive, Sleep Apnea, Central
DreamKit Respiratory Effort Signal Validation
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
- Trial name
- NCT04926077
- Testing
- DreamKit
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Colonic Polyp, Colonic Neoplasms
Validation of Aer-O-Scope Colonoscope System Cecal Intubation
61 subjects (male or female) between the ages of 45 and 75 will undergo colonoscopy. The primary outcome is Cecal Intubation
- Conditions
- Colonic Polyp, Colonic Neoplasms, Colonic Diseases, Colon Adenoma
- Trial name
- NCT03949777
- Testing
- Aer-O-Scope Colonoscopy
- Where
- Israel
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- GI View Ltd.