Clinical trials: VALİDİTY
Influenza
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza…
- Trial name
- NCT01431768
- Testing
- Respirio Flu Test
- Where
- 2 sites in Australia
- Volunteers
- 250 people
- Sponsor
- Respirio Pty Ltd
Epilepsy
Formative Validation of the MoveChecker System
obtain motion sequences of at least 60 epileptic seizures
- Trial name
- NCT05824611
- Testing
- collect movement data from epileptic seizures
- Where
- 4 sites in Germany
- Volunteers
- 53 people
- Sponsor
- Gaia AG
Allergy, Allergic Asthma
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA…
- Conditions
- Allergy, Allergic Asthma, Allergy to Cats, Allergy to House Dust
- Trial name
- NCT04442932
- Testing
- Blood Collection
- Where
- 5 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abionic SA
Tinnitus
Efficacy of the Erchonia Corporation THL™ for Providing Relief of Tinnitus Symptoms
The purpose of this clinical study is to determine the effectiveness of the Erchonia® THL™, manufactured by Erchonia Corporation (the Company), for prescription home use in providing relief of tinnitus symptoms when used by…
- Trial name
- NCT05374421
- Testing
- Erchonia® THL™
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Erchonia Corporation
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
Bladder Cancer
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay
The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer.
- Trial name
- NCT05643690
- Testing
- UriFind Bladder Cancer Assay
- Where
- 2 sites in United States
- Volunteers
- 77 people
- Sponsor
- AnchorDx Medical Co. Ltd. US
Infiltration of Peripheral IV Therapy
Milky Way Sensor: Device Validation for Infiltrated Tissues
A single arm trial consisting of 28 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
- Trial name
- NCT07311733
- Testing
- ivWatch Model 400 with Milky Way Sensor
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Heart Failure
Withings HFRN Retrospective Study
This is a fully decentralized retrospective, non-interventional study evaluating the diagnostic performance of the Withings Heart Function Risk Notification (HFRN), a software-only medical device (SaMD)
- Trial name
- NCT07654491
- Testing
- Withings Heart Function Risk Notification (HFRN), Claims-based heart-failure adjudication (reference standard)
- Where
- France
- Volunteers
- 9,000 people, healthy volunteers welcome
- Sponsor
- Withings
Sleep Disorder
Validation Study of a Patch-based PSG System
This study is a study that qualifies as "other clinical investigation" under Art. 82 MDR and §47 Abs. 3 MPDG with a CE-marked device that aims to demonstrate that the physiological signals from the Onera STS system are…
- Trial name
- NCT05310708
- Testing
- Polysomnography
- Where
- 7 sites in Germany
- Volunteers
- 300 people
- Sponsor
- Onera BV
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
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
Mesothelioma, Small Cell Lung Cancer, NSCLC
Validation of the MiCK Assay
Testing Mayo Clinic cancer patients with the results being correlated with prior patient therapy, performance status, and extent of disease.
- Trial name
- MiCK Assay (NCT01770665)
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Pierian Biosciences
Brain Injuries
Validation Of TBI Detection System For Head Injured Patients
A prospective, non-randomized trial to validate the database of brain electrical activity recordings and clinical information collected from patients who present to the ED following closed head injury.
- Trial name
- B-AHEAD III (NCT02367300)
- Testing
- BrainScope Ahead 200
- Where
- 11 sites in United States
- Volunteers
- 981 people
- Sponsor
- BrainScope Company, Inc.
Lung Cancer
CASCADE-LUNG: Cancer Screening Assay Using DELFI; A Clinical Validation Study in Lung
CASCADE-LUNG is a multisite, prospective, observational, blood specimen collection study in the elevated-risk lung cancer screening population.
- Trial name
- DELFI-L201 (NCT05306288)
- Testing
- Blood Sample Collection
- Where
- 67 sites in United States, Puerto Rico
- Volunteers
- 11,935 people
- Sponsor
- Delfi Diagnostics Inc.
Amblyopia, Anisometropic, Amblyopia Strabismic
Validation of New Virtual Reality Treatment for Children With Lazy Eye Using the Vedea Amblyopia Therapy (VAT)
The purpose of this clinical study is to validate the effectiveness of the Vedea Amblyopia Therapy (VAT) as a treatment for children with lazy eye.
- Conditions
- Amblyopia, Anisometropic, Amblyopia Strabismic, Amblyopia
- Trial name
- VAT (NCT05620173)
- Testing
- Vedea Amblyopia Therapy (VAT), Occlusion therapy
- Where
- 2 sites in Netherlands
- Volunteers
- 74 people
- Sponsor
- Vedea Healthware BV
Cognitive Functioning of Healthy Individuals
Norms Expansion and Validation for IntelliSpace Cognition
This study aims to expand the normative dataset for Philips IntelliSpace Cognition to include ages 18-49 and 80+ and aims to validate two new digital tests.
- Trial name
- NCT04729257
- Testing
- Philips IntelliSpace Cognition (ISC)., Paper-Pencil Tests.
- Where
- United States
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Mild Cognitive Impairment
A Study of a Self-Administered Memory Screening Test With Automated Reporting (SAMSTAR) in Participants With Mild Cognitive Impairment
The purpose of this study is to evaluate the psychometric properties of a Self-administered Memory Screening Test with Automated Reporting (SAMSTAR) adapted from the Rey Auditory Verbal Learning Test (RAVLT) in normal control…
- Trial name
- NCT02419183
- Testing
- SAMSTAR, RAVLT
- Where
- 2 sites in United States
- Volunteers
- 153 people
- Sponsor
- Janssen Research & Development, LLC
Major Depressive Disorder
A Study to Assess Serotonin Transporter Occupancy of Healthy Adults Using 11C-DASB PET
This study was a non-randomized, open-label clinical study to assess Serotonin transporter occupancy in the brain of healthy adults using 11C-DASB positron emission tomography (PET)
- Trial name
- NCT06476509
- Testing
- LV232 40mg, Escitalopram 20 mg, LV232 60mg
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Vigonvita Life Sciences
Onychomycosis
Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to…
- Trial name
- NCT05626270
- Testing
- LunulaLaser OTC
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Erchonia Corporation
Obstructive Sleep Apnea
PSG Validation of MATRx Plus AHI
Obstructive sleep apnea (OSA) is a common disease that carries significant risks for cardiovascular disease, mortality, and economic costs.
- Trial name
- NCT03627169
- Testing
- MATRx plus
- Where
- Canada
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Zephyr Sleep Technologies