Clinical trials: VALİDİTY
Healthy
Validation of Avocatin b as a Biomarker of Food Intake
The primary objectives are to Identify avocatin b (C17 lipid) in plasma of individuals that consumed 1 avocado. Confirm no avocation b present in the plasma of individuals that avoided avocado intake for 7 days.
- Trial name
- AVOC5 (NCT05009420)
- Testing
- Avocado
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Clinical Nutrition Research Center, Illinois Institute of Technology
Parkinson Disease, Deep Brain Stimulation
Validation of HaGuide Software Module Accuracy in Mapping STN Boundaries in Parkinson's Disease Patients Who Underwent DBS Procedure
HaGuide version 1.0 (Neuro-Omega Ltd.) is a software module add-on to the FDA cleared Neuro-Omega System (K123796). It was designed to facilitate the use of Neuro-Omega's system by automatically mapping visually the depth of STN…
- Trial name
- NCT03363724
- Testing
- HaGuide version 1.0 software module
- Volunteers
- 103 people
- Sponsor
- Alpha Omega Engineering Ltd.
Healthy
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00029
ORi is a unitless index that could help clinicians with their assessments of normoxic and hyperoxic states by scaling the measured absorption information between 0.00 and 1.00.
- Trial name
- NCT04079842
- Testing
- INVSENSOR00029
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
Patient-Reported Outcomes (PRO)
Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument
- Trial name
- NCT03536715
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- AcuFocus, Inc.
Endometriosis
Multicenter Study for Diagnostic Validation of a Laboratory Test for the Diagnosis of Endometriosis
Endometriosis affects at least 1 in 10 women worldwide and is associated with a diagnostic delay of 5-10 years. Currently, definitive diagnosis requires invasive laparoscopy, which is costly and burdensome for patients.
- Trial name
- NCT07553676
- Where
- 8 sites in Austria, Germany
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Diamens FlexCo
Stroke, Gait Disorders, Neurologic
REEV SENSE for Gait Analysis in Post-stroke Gait Impairment (SENS-AG)
The purpose of this study is to evaluate the clinical performance of the investigational REEV SENSE gait tracker to measure gait features in subjects with post-stroke gait impairment.
- Trial name
- SENS-AG (NCT06234878)
- Testing
- REEV SENSE, Motion capture system
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- REEV LLC
Supplemental Oxygen
Follow-Up to the Usability Evaluation of a Portable Oxygen Concentrator
This study was a follow-up evaluation of modifications made to the instructions in the User Manual following the initial study evaluating how well an individual can put together and use a Portable Oxygen Concentrator (POC).
- Trial name
- NCT04358848
- Testing
- X-PLO2R
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Belluscura LLC
Influenza Human
Clinical Validation of the Point-of-Care MSD Influenza Test
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
- Trial name
- NCT00863343
- Testing
- Public Health Notification
- Where
- 3 sites in United States
- Volunteers
- 391 people
- Sponsor
- Meso Scale Diagnostics, LLC.
Genotyping Techniques
Spartan Cube CYP2C19 Method Comparison Study
The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing.
- Trial name
- NCT04473586
- Testing
- Spartan Cube CYP2C19 System
- Where
- Canada
- Volunteers
- 425 people, healthy volunteers welcome
- Sponsor
- Spartan Bioscience Inc.
Growth Hormone Deficiency With Pituitary Anomalies
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial.
- Trial name
- NCT02558829
- Testing
- Macimorelin, Insulin
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- AEterna Zentaris
Coronary Artery Disease, Cardiovascular Diseases
A Novel Non-Invasive Acoustic Diagnostic for the Diagnosis of Coronary Artery Disease The CAD-det Validation Study
The purpose of the study is to collect acoustic, ECG, and clinical data from consenting participants, so that AusculSciences can perform analysis on the sounds produced by the heart and determine the accuracy of the CAD-det…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Atherosclerosis, Coronary Occlusion
- Trial name
- NCT04562142
- Testing
- CAD-det
- Where
- 2 sites in Canada
- Volunteers
- 395 people
- Sponsor
- AusculSciences Canada Inc.
Pulmonary Embolism
External Validation of a Deep Learning Based Model for Pulmonary Embolism Detection on Chest CT Scans
The scope of this study is the external validation of an explainable deep learning-based classifier for the diagnosis and detection of pulmonary embolism in computed tomography pulmonary angiography (CTPA) and contrast enhanced…
- Trial name
- NCT05333042
- Where
- Belgium
- Volunteers
- 5,000 people
- Sponsor
- OncoRadiomics
Obstructive Sleep Apnea
Patient Perception Questionnaire Validation
Validation of the patient perception questionnaire relating to CPAP use
- Trial name
- NCT02067000
- Testing
- Obstructive Sleep Apnea
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Fisher and Paykel Healthcare
Gastric Motor Function
Clinical Validation of the VIPUN GMS as a Gastric Motility Monitoring System
In order to validate that the VIPUN, Gastric Monitoring System (GMS) is a gastric motility monitoring system, we intend to show that the VIPUN GMS can assess motility through pressure measurement similar to high-resolution…
- Trial name
- NCT05264363
- Testing
- VIPUN Gastric Monitoring System prototype
- Where
- Belgium
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- VIPUN Medical
Right Heart Catheterization
The Nanowear Wearable System SimpleSense Validation Trial for Cardiac Output
The Nanowear SimpleSense study is a single center, prospective, non-randomized, feasibility, non- significant risk study The study will be done in 2 phases.
- Trial name
- NCT05629533
- Testing
- SimpleSense
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Nanowear Inc.
Skin Cancer
Development and Validation of a New Digital Dermatoscope in the United States
A completely new type of digital dermatoscope has been developed in order to take a significant step forward in technology for skin cancer imaging.
- Trial name
- NCT04047316
- Testing
- Digital dermoscopy
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Barco NV
Psychological Well Being
Test-Retest Reliability of the WB6Dim Digital Well-Being Tool: A 3-Day Interval Study
This study aims to establish the test-retest reliability of the WB6Dim digital self-assessment tool across its eight well-being dimensions, using a 3-day interval protocol designed to minimize the probability of genuine…
- Trial name
- WB6Dim-TRT (NCT07433764)
- Where
- France
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Clover Link
Coronary Artery Disease, Coronary Arteriosclerosis
Validation of an Intracycle CT Motion CORrection Algorithm for Diagnostic AccuracY
To demonstrate the incremental utility of SSF for individuals undergoing CCTA, with expected improvements in image quality and diagnostic accuracy.
- Trial name
- VICTORY (NCT01856504)
- Where
- 7 sites in United States, Argentina and 3 more
- Volunteers
- 218 people
- Sponsor
- MDDX LLC
Healthy
BodyGuardian Respiration and Activity Validation Testing
This project will compare BodyGuardian (BG) device measurements of breathing and activity levels to the gold standard measurement techniques of gas exchange using a mouthpiece connected to flow and gas analyzers measures for…
- Trial name
- NCT02255526
- Testing
- BodyGuardian
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Preventice
Small Intestine Disease, Small Intestine Cancer
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
Observational, Multicenter, Post-market, Minimal risk, Prospective data collection of PillCam SB3 videos (including PillCam reports) and raw data files and optional collection of Eneteroscopy reports
- Conditions
- Small Intestine Disease, Small Intestine Cancer, Small Intestinal Ulcer Bleeding, Small Intestine Obstruction
- Trial name
- SODA (NCT03771508)
- Where
- 30 sites in United States
- Volunteers
- 3,712 people
- Sponsor
- Medtronic - MITG