Clinical trials: System Validation
Developmental Disability, Intellectual Disability
Validation of Optical Genome Mapping for the Identification of Constitutional Genomic Variants in a Postnatal Cohort
The purpose of this research use only (RUO) study is to detect genomic structural variants (SVs) in human DNA by Optical Genome Mapping (OGM) using the Bionano Genomics Saphyr system.
- Conditions
- Developmental Disability, Intellectual Disability, Autism Spectrum Disorder, Congenital Anomaly
- Trial name
- NCT05295277
- Testing
- Standard of care genetic testing group
- Where
- 8 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Bionano Genomics
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.
Stroke
Validation of an Electroencephalograph Based Algorithm for Detection of Onset and Deterioration of Acute Ischemic Stroke by Comparison to NIHSS
The purpose of this study is the validation of an Electroencephalograph based algorithm for detection of onset and deterioration of Acute Ischemic Stroke by Comparison to NIHSS.
- Trial name
- NCT01738412
- Testing
- Neurokeeper stroke detector
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Neurokeeper Technologies
Hypotension
Clinical Validation of Vital-PICASO for Predicting Hypotension Within 24 Hours in General Ward Inpatients
This retrospective study evaluated the clinical performance of Vital-PICASO, an artificial intelligence-based biological signal analysis software designed to predict the risk of hypotension within 24 hours using vital-sign data…
- Trial name
- NCT07742930
- Where
- South Korea
- Volunteers
- 648 people
- Sponsor
- Huinno AIM
Calibration and Validation of Analyte Testing System
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1
The purpose of the Kaligia Biosciences KBS Systems 1.0(b) analyte monitoring device is to measure the blood analyte levels in patients.
- Trial name
- NCT04305938
- Testing
- Minimally invasive and non-invasive blood analyte measurement
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Kaligia Biosciences, LLC
Fluid Retention Tissue
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device.
- Trial name
- MaTcH (NCT03072732)
- Testing
- u-Cor System, ZOE Fluid Status Monitor
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
Seizures, Motor, Seizures
Study to Validate Novel Seizure-Detection Algorithm
The specificity and sensitivity of a novel seizure-detection mobile software application with a generalized tonic/clonic seizure detection algorithm (Motor Seizure Detection Algorithm [mSDA]) installed on a wearable device to be…
- Conditions
- Seizures, Motor, Seizures, Seizure Disorder, Epilepsy
- Trial name
- NCT04291716
- Testing
- Motor Seizure Detection Algorithm (mSDA)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Overwatch Digital Health
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
Heart Failure
Avicena LVDP Validation Study
The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during…
- Trial name
- NCT05633004
- Testing
- Vivio
- Where
- United States
- Volunteers
- 406 people
- Sponsor
- Ventric Health, LLC
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
Multiple Sclerosis
ETNA-MS Device Validation Study
The overarching goal of this research protocol is to validate the effectiveness of Innodem's ETNA-MS device in informing clinicians on the disability status of Multiple Sclerosis (MS) patients.
- Trial name
- ETNA-MS (NCT06256731)
- Testing
- Eye-Tracking
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Innodem Neurosciences
Pulmonary Disease, Chronic Obstructive
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
The prevalence, low cost, and low burden of wearable devices that provide quantitative and qualitative feedback on a subject's activity level present an opportunity for the use of these devices in clinical and observational…
- Trial name
- NCT02619357
- Testing
- SenseWear Armband Gecko, SenseWear Armband MF, Actigraph GT9x wristband and waistband
- Where
- United Kingdom
- Volunteers
- 22 people
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus
Validation Study of G4 User Interface
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.
- Trial name
- G4 (NCT01142895)
- Volunteers
- 33 people
- Sponsor
- Tandem Diabetes Care, Inc.
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.
Alzheimer Disease, MCI
Validation Study of a New Digital Treatment Test
Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems.
- Trial name
- NCT04897464
- Testing
- BGaze therapy Alzheimer
- Where
- Spain
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Braingaze
Allergic Rhinitis, Rhinitis, Allergic, Seasonal
Investigate Two Trial Models; Vienna Challenge Chamber (in and Out of Season) and Park Study (in Season) Using a Drug for Seasonal Allergic Rhinitis
The aim of the study is to investigate the trial models, Vienna Challenge Chamber (VCC), in and out of season, and Park Study in season and the clinical efficacy of repeat doses of fluticasone propionate in subjects with seasonal…
- Trial name
- NCT00400998
- Testing
- Fluticasone Propionate
- Where
- Austria
- Volunteers
- 41 people
- Sponsor
- Research Consult GmbH
Laryngopharyngeal Reflux (LPR)
Quality of Life Validation in Laryngitis
The primary purpose of this study was to establish the psychometric properties of a new disease specific Quality of Life questionnaire, the LPR-HRQL.
- Trial name
- NCT00641264
- Testing
- Omeprazole, Quality of Life questionnaire
- Volunteers
- 90 people
- Sponsor
- AstraZeneca
Diabetes Mellitus, Chronic Obstructive Pulmonary Disease
Validation of Medication Non-adherence Model (UK)
Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers.
- Conditions
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Chronic Illness, Primary Care
- Trial name
- NCT02115412
- Where
- 4 sites in United Kingdom
- Volunteers
- 750 people
- Sponsor
- Philips Healthcare
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