Clinical trials: Validation Studies
Hair Loss, Hair Loss/Baldness
HairDx Analytical Validation Study
The HairDx Test reports genetic variants associated with the development of FPHL.
- Conditions
- Hair Loss, Hair Loss/Baldness, Female Pattern Baldness, Androgenetic Alopecia
- Trial name
- NCT04379583
- Testing
- HairDx Sample Collection Kit
- Where
- United States
- Sponsor
- Applied Biology, Inc.
Infection
Identigene STD Test Collection Kit Validation Study
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory.
- Trial name
- NCT01471392
- Testing
- STD Diagnostic Kit (Identigene)
- Where
- United States
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Identigene
ECG, Electrocardiography
Validation of Perin Health Patch ECG Monitoring Device Performance and Placement Accuracy
The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older.
- Conditions
- ECG, Electrocardiography, Monitoring, Physiologic
- Trial name
- NCT07147920
- Testing
- Chest-Worn ECG Monitoring Device
- Where
- United States
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Fertility Risk
Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study
To demonstrate that clear, interpretable quality images of the ovaries and uterus can be generated using a portable transvaginal ultrasound scanner in the home environment, and that those images are interpretable by physicians…
- Trial name
- SELF-HELP (NCT04687189)
- Testing
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Turtle Health, Inc.
Male Infertility
A Novel Sperm Selection Method Provides Advantages Over Conventional Approaches
The goal of this clinical trial is to know if a novel sperm selection device (CA0) has a similar performance than the standard selection method in teratozoospermic and azoospermic men.
- Trial name
- NCT06545318
- Testing
- Density Gradient Centrifugation, CA0 chamber
- Where
- Mexico
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Center of Innovation Technology & Reproductive Medicine
Ultrasound Imaging of Anatomical Structures
A Study to Collect Imaging Data for the Validation of the Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block (PNB) - US v1.0
This is a single-center, prospective study to be undertaken at University of Oregon, Portland, USA. The aim is to evaluate the clinical performance of ScanNav Anatomy PNB when highlighting anatomical structures during UGRA…
- Trial name
- NCT04906018
- Testing
- Ultrasound scans
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IntelligentUltrasound Limited
Pregnant Individuals, Aneuploidy
The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment
The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of…
- Conditions
- Pregnant Individuals, Aneuploidy, Down Syndrome (Trisomy 21), 22q11.2 Deletion Syndrome
- Trial name
- ADVANCE (NCT07643896)
- Where
- 9 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- BillionToOne 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
Non Invasive Blood Pressure
Philips Non-Invasive Blood Pressure Validation Study of VS30 Monitor
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population.
- Trial name
- NCT06980766
- Testing
- Non Invasive Blood Pressure
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Cardiovascular Disease
X-ray Dose Reduction Study for Endovascular Interventional Radiology
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly.
- Trial name
- NCT01599741
- Testing
- Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology., Normal dose DSA with conventional X-ray imaging technology
- Where
- Netherlands
- Volunteers
- 51 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Pulmonary Disease, Chronic Obstructive
Korean Chronic Obstructive Pulmonary Disease(COPD) Assessment Test Validation Study
This is a cross-sectional validation study, designed to evaluate the discriminative validity of the Chronic Obstructive Pulmonary Disease Assessment Test translated in a local language in patients with Chronic Obstructive…
- Trial name
- CAT (NCT01424527)
- Where
- 5 sites in South Korea
- Volunteers
- 100 people
- Sponsor
- GlaxoSmithKline
Non Invasive Blood Pressure
Philips Non-Invasive Blood Pressure Validation Study
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population.
- Trial name
- NCT06682312
- Testing
- Non-invasive blood pressure
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Anesthesia
A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
This study is a multi-center (each center independently conducts the study according to the same research protocol), randomized, and open-label clinical study.
- Trial name
- NCT06740201
- Testing
- Cipepofol
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
ARDS (Acute Respiratory Distress Syndrome)
Observational, Non-interventional Biomarker and Endotyping Study
The goal of this observational study is to establish a centralized ARDS biorepository of longitudinal biospecimens and harmonized clinical data, develop unsupervised, therapy-agnostic endotyping algorithms, and develop…
- Trial name
- OBSERVE-ARDS (NCT07675265)
- Where
- United States
- Volunteers
- 1,200 people
- Sponsor
- Prenosis, Inc.
Blood Pressure Measurement
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
The main purpose of this study is to assess the equivalence between blood pressure measurements obtained using the Philips iNIBP system and those determined by the auscultatory reference method.
- Trial name
- iNIBP (NCT07901608)
- Testing
- Blood Pressure Measurement
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Hypoxia
Polso SpO2 Accuracy Validation Study
The purpose of this study is to validate the oxygen saturation (SpO2) accuracy of the Polso Monitoring System during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03735329
- Testing
- Diagnostic test of SPO2
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- ChroniSense Medical Ltd.
Pathology
Instrument Precision Study for Validation of PIPS 5.1
This study is designed to evaluate the instrument precision of the device for its proposed intended use in sub-studies: intra-system and inter-system.
- Trial name
- NCT04879056
- Testing
- PIPS 5.1
- Where
- United States
- Volunteers
- 399 people
- Sponsor
- Philips Digital & Computational Pathology
Healthy, Sleep Deprivation
Smart Sleep In-home Validation Extension Study
This study is a nonrandomized, unblinded, uncontrolled case series clinical trial validating the SmartSleep product, including SleepMapper app in the home setting.
- Conditions
- Healthy, Sleep Deprivation, Insufficient Sleep Syndrome
- Trial name
- NCT03665844
- Testing
- SmartSleep Boost On, SmartSleep Boost Off
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Philips Respironics
Flushing
Endpoint Validation Study (0524A-015)
To determine the most effective daily dose of MK0524A when compared with placebo after the 8-week treatment period for Niacin Induce Flushing (NIF).
- Trial name
- NCT00533676
- Testing
- MK0524A, /Duration of Treatment : 8 Weeks
- Volunteers
- 165 people
- Sponsor
- Merck Sharp & Dohme LLC
Sleep Apnea
Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.
- Trial name
- NCT03635918
- Testing
- NightOwl HSAT
- Where
- Belgium
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Ectosense NV