Clinical trials: Validation Studies
Cognitive Impairment, Motor Disorders
Linus Health CDS Retrospective Validation Study
This study is a retrospective validation study of deidentified Clinical Decision Support (CDS) recommendations generated by the Linus Health Core Cognitive Evaluation (CCE) for patients who have completed the CCE.
- Conditions
- Cognitive Impairment, Motor Disorders, Dementia
- Trial name
- NCT05900310
- Testing
- Core Cognitive Evaluation (CCE)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Linus Health, Inc.
Cancer of the Pancreas, Pancreatic Cancer
Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired…
- Conditions
- Cancer of the Pancreas, Pancreatic Cancer, Pancreas Neoplasms, Pancreatic Carcinoma Stage I
- Trial name
- VERIFI (NCT06947395)
- Testing
- PancreaSure
- Where
- 6 sites in United States
- Volunteers
- 386 people
- Sponsor
- Immunovia, Inc.
Head and Neck Squamous Cell Carcinoma, Non Small Cell Lung Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood and Primary Tumor in HNSCC/NSCLC/Melanoma
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Conditions
- Head and Neck Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Melanoma
- Trial name
- NCT04490564
- Testing
- PD-L1 Kit
- Where
- 6 sites in Greece
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
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.
OSA
Prospective Study for the Clinical Validation of the Soundi Wearable Medical Device
This is a pre-marketing, single-centre, prospective clinical trial with the aim of comparison the effectiveness and safety of the SOUNDI medical device compared to polysomnography in detecting parameters for the diagnosis of…
- Trial name
- SOUNDI (NCT06320795)
- Testing
- SOUNDI
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Biocubica srl
Asthma in Children
Leo Study Unstable Asthma
This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children.
- Trial name
- NCT05308277
- Testing
- Leo device monitoring
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ResMed
Macular Degeneration, Geographic Atrophy
A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
The goal of this observational study is to assess the reliability and validity of the 9-object MLSDT for evaluation of participants with moderate to severe vision impairment when tested without a wearable low-vision magnifying…
- Conditions
- Macular Degeneration, Geographic Atrophy, Stargardt Disease
- Trial name
- NCT06805474
- Testing
- Observational
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nanoscope Therapeutics Inc.
Respiratory Rate
Sensor Validation Study - Quality Assurance
The respiratory rate is an important parameter in clinical medicine. It is defined as the number of breaths per minute. Currently this is measured at the bedside in clinical practice by counting the breaths, however the gold…
- Trial name
- NCT03306537
- Testing
- RespiraSense Respiratory Rate Monitor
- Where
- United Kingdom
- Volunteers
- 34 people
- Sponsor
- PMD Solutions
Systemic Inflammatory Response Syndrome (SIRS), Sepsis
IMproved PREdiction of Severe Sepsis in the Emergency Department
The purposes of this study is to determine whether Heparin Binding Protein (HBP) can be used as a marker of severe sepsis (including septic shock) in patients presenting to the emergency department with suspected infection.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Sepsis, Severe Sepsis, Septic Shock
- Trial name
- IMPRESSED (NCT01392508)
- Where
- 5 sites in United States, Sweden
- Volunteers
- 759 people
- Sponsor
- Axis Shield Diagnostics Ltd
Malignant Melanoma
Melanoma Image Analysis Algorithm (MIAA) Validation Study
Prospective, single-arm, cross-sectional, study to establish the effectiveness of MIAA to detect melanoma in pigmented lesions, compared to gold standard histological determination.
- Trial name
- NCT02612168
- Testing
- Melanoma Image Analysis Algorithm (MIAA)
- Where
- 7 sites in United Kingdom
- Volunteers
- 514 people
- Sponsor
- Skin Analytics Limited
Hypoxia
BiOSENCY BORA Band SpO2 Validation Study
The purpose of this clinical study is to validate the SpO2 accuracy of the BiOSENCY BORA BAND™ wristband Pulse Oximeter during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by…
- Trial name
- NCT03918018
- Testing
- BORA Band SpO2 Validation Study
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Biosency
Shortness of Breath
A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
The purpose of this study is to assess the efficacy of Caption LungAI.
- Trial name
- NCT05992324
- Testing
- Caption LungAI
- Where
- 4 sites in United States
- Volunteers
- 220 people
- Sponsor
- Caption Health, Inc.
Colorectal Cancer, Polyps
Clinical Validation of Stool DNA-based SDC2 Methylation Test for Colorectal Cancer Detection
Pivotal trials of SDC2 methylation biomarker test in stool DNA to estimate clinical sensitivity and specificity in detection of colorectal cancer.
- Conditions
- Colorectal Cancer, Polyps, Other Cancers, Healthy
- Trial name
- NCT03146520
- Testing
- EarlyTect Colon Cancer
- Where
- South Korea
- Volunteers
- 634 people, healthy volunteers welcome
- Sponsor
- Genomictree, Inc.
Healthy Volunteer Study
An Open-label, Non Significant Risk, Adhesive Wear Validation Study for the On Body Drug Delivery Device Component of the SQIN-01 Furosemide Infusor (Infusor Device)
The purpose of the present study is to test the adequacy, performance and skin reactivity of the adhesive tape to be utilized in the to-be-marketed Device.
- Trial name
- NCT04836572
- Testing
- 3M 1529 Adhesive Tape
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- SQ Innovation, Inc.
Major Depressive Disorder
Using Voice Biomarkers to Predict the Likelihood of Major Depressive Disorder
Major Depressive Disorder (MDD) is the leading cause of disability worldwide. Depression and anxiety disorders are among the most prevalent of all mental disorders, with an estimated annual prevalence of 9.7% and 18.1%…
- Trial name
- NCT04874077
- Where
- 2 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Kintsugi Mindful Wellness, Inc.
Lung Cancer Diagnosis
Clinical Validation of Freenome Multiomics Blood Test for Lung Cancer Screening
The PROACT LUNG study is a prospective multi-center observational study to validate a blood-based test for the early detection of lung cancer by collecting blood samples from high-risk participants who will undergo a routine…
- Trial name
- PROACT-LUNG (NCT06122077)
- Testing
- blood draw
- Where
- 36 sites in United States
- Volunteers
- 20,000 people
- Sponsor
- Freenome Holdings Inc.
Low Back Pain, Neck Pain
Wearable Spine Assessment in Adults With and Without Low Back or Neck Pain
This is a single-site, prospective, observational, single-visit feasibility and validity study. Adult participants with and without low back or neck pain will be screened, consented, and enrolled to undergo a structured…
- Trial name
- AxiSens-01 (NCT07643207)
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Ashkan Vaziri
Atopic Dermatitis
Scratching Validation Study
Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic…
- Trial name
- NCT05137093
- Testing
- Actigraphy Device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Heart Valve Disease
Validation of Naevia Medical in Valvulopathies
The study aims to validate naevia medical, a knowledge-based clinical decision support system (CDSS), for clinical benefit and safety in cases of cardiac valvulopathies.
- Trial name
- CDSS-Valve (NCT06392464)
- Testing
- Clinical decision support system (software)
- Where
- Spain
- Volunteers
- 106 people
- Sponsor
- Dilemma Solutions S.L.
Pulmonary Arterial Hypertension
Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH
Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH. To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment…
- Trial name
- NCT02112487
- Testing
- Macitentan
- Where
- 32 sites in France, Italy and 1 more
- Volunteers
- 88 people
- Sponsor
- Actelion