Clinical trials: VALİDİTY
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
Allergic Rhinitis, Rhinoconjunctivitis
Red Maple Trials Cat Allergen Natural Exposure Chamber Validation in Cat-allergic Subjects
To assess the reproducibility of the allergic response in the cat allergic subjects, measured as the change from baseline of the Total Nasal Symptom Score (TNSS) on the two challenge days.
- Conditions
- Allergic Rhinitis, Rhinoconjunctivitis, Exposure
- Trial name
- NEC (NCT03414801)
- Testing
- Allergen Exposure
- Where
- Canada
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Red Maple Trials Inc.
Stroke, Acute Ischemic Stroke
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s)…
- Trial name
- VOICE (NCT05547412)
- Testing
- NovaGuide 2 Intelligent Ultrasound System
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Cancer
Entia Liberty: Accuracy and Precision
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers.
- Trial name
- NCT05025124
- Testing
- Entia Liberty
- Where
- United Kingdom
- Volunteers
- 530 people
- Sponsor
- Entia Ltd
SARS-CoV-2 Infection, Influenza A
Usability and Clinical Validation of the Flu A/B/COVID-19 + RSV Multiplex Rapid Test
This will be a prospective study for the clinical validation of the CorDx Tyfast Flu A/B/COVID-19 + RSV Multiplex Rapid Test for the qualitative detection and differentiation of SARS-CoV-2, Influenza A, Influenza B and RSV in AN…
- Conditions
- SARS-CoV-2 Infection, Influenza A, Influenza B, RSV
- Trial name
- CorDx 4in1 (NCT07875270)
- Testing
- Flu A/B/COVID-19 + RSV Multiplex Rapid Test
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- CorDx, Inc.
Pancreatic Cancer
EpiDetect Study: Clinical Validation of a Pancreatic Cancer Detection Test in New-Onset Diabetes Patients
Bluestar Genomics has developed a non-invasive test that aids in the qualitative detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older.
- Trial name
- NCT05188573
- Testing
- Early detection pancreatic cancer test, Early detection pancreatic cancer test and MRI Imaging
- Where
- United States
- Sponsor
- ClearNote Health
Heart Failure
LifeVest Trends Validation Protocol
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).
- Trial name
- TRENDS (NCT02149290)
- Testing
- Trends-equipped LifeVest 4000
- Where
- 21 sites in United States, Austria and 1 more
- Volunteers
- 198 people
- Sponsor
- Zoll Medical Corporation
Severe Native Calcific Aortic Stenosis, Symptomatic Heart Disease Due to Severe Native Calcific Aortic Stenosis
Validation Of anatomY-specific Aortic Valve Implantation Guided by Software Using EncantoR
VOYAGER CE Clinical Study using the Encantor TAVI System.
- Trial name
- VOYAGER CE (NCT07696182)
- Testing
- Prospective, single-arm, multi-center study.
- Volunteers
- 150 people
- Sponsor
- Abbott Medical Devices
Validation of Oximeter System
Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.
- Trial name
- NCT01908790
- Testing
- Mespere Venous Oximeter, Avoximeter 4000
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Mespere Lifesciences Inc.
Parkinson's Disease With Freezing of Gait
Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease
The goal of this clinical trial is to learn if the cueStim device can reduce the duration of freezing of gait (FoG) that occurs in patients with Parkinson's Disease.
- Trial name
- NCT07675408
- Testing
- CueStim
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Fortis Medical Devices Limited
Healthy
Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed
The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population.
- Trial name
- NCT04268017
- Testing
- FeetMe Monitor
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- FeetMe
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
Severe Infection, Sepsis
Evaluation of MDW for Early Detection of Sepsis, Clinical Validity
The purpose of this study is to confirm the clinical validity and the performance of the Monocyte Width Distribution (MDW) parameter to detect the development of sepsis in a prospective study of Emergency Department (ED) adults…
- Conditions
- Severe Infection, Sepsis, Severe Sepsis
- Trial name
- NCT03588325
- Testing
- CBC-DIFF with MDW, PCT, CRP
- Where
- 2 sites in France, Spain
- Volunteers
- 947 people
- Sponsor
- Beckman Coulter, Inc.
Cardiac Arrhythmia, Atrial Fibrillation
Vektor vMap™ Clinical Validation Study
This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping…
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation, Ventricular Arrythmia, Premature Ventricular Complexes Multiple
- Trial name
- NCT04559061
- Testing
- Cardiac ablation procedure
- Where
- 4 sites in United States
- Volunteers
- 225 people
- Sponsor
- Vektor Medical
Pre-surgical Anxiety, Blood Glucose Concentration
Vis Pre Surgery Medical Food Validation Study
A pre-market, confirmatory, prospective, interventional, clinical investigation to confirm the clinical safety and performance profile of Vis Pre-surgeryTM that the medical food will reduce pre and post-surgical complications…
- Conditions
- Pre-surgical Anxiety, Blood Glucose Concentration, Blood Cortisol Levels, Electrolyte Levels
- Trial name
- NCT07359222
- Testing
- Pre-surgical medical food
- Where
- India
- Volunteers
- 67 people
- Sponsor
- TM Nutrition LLC
Psychological Well Being
Digital Self-Assessment of Well-Being: Validation of the Libellules Tool Against Gold-Standard Psychological Scales
The Libellules (WB6Dim) study aims to validate a digital self-assessment tool for measuring individual well-being across six dimensions: sleep and recovery, emotional climate, self-esteem, perceived autonomy, energy reservoir…
- Trial name
- NCT07301879
- Where
- France
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Clover Link
Eye Movement
Development and Validation of a Novel Eye-Tracking Software-based Platform to Extract Oculometric Measures
This is an observational prospective study in a cohort of healthy subjects who are enrolled using convenience and snowballing sampling.
- Trial name
- NCT05476523
- Testing
- NeuraLight
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- NeuraLight
Infectious Disease, Tropical Disease
Collection of Human Biological Samples for the Development and Validation of New Methods of Diagnosis and for the Realization of Expertises Diagnostics in the Field of Infectious Diseases and Tropical
Direct constitution of collections from various samples taken on a prospective cohort of healthy volunteers, to prepare human biological samples of known characteristics (biochemical and serological in particular) and quality…
- Trial name
- Diagmicoll (NCT03912246)
- Testing
- biological samples, lumbar puncture
- Where
- 2 sites in France
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
Healthy
Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular Disease
Specificity measure of performance of the Irregular Heartbeat Detection algorithm (evaluated for the finger and wrist form factors) against the Masimo Radius VSM® reference ECG.
- Trial name
- NCT07223164
- Testing
- Masimo SET® and Masimo W1®
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation