Clinical trials: Validation Studies
Haemophilia A
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical…
- Trial name
- OPTIMS (NCT01436825)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in France, Italy
- Volunteers
- 69 people
- Sponsor
- Bayer
Infertility, ART
Automation of the In Vitro Fertilization Laboratory
Enrolled patients will undergo an Assisted Reproductive technology (ART) treatment using intracytoplasmic sperm injection (ICSI, the direct injection of a single sperm cell into an oocyte) as the method of insemination.
- Trial name
- NCT06581068
- Testing
- AURA assisted ART treatment
- Where
- 2 sites in Mexico
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Conceivable Life Sciences
Hemodynamics
Design Validation Hemodynamic Study of New Kendall SCD SmartFlow Compression System
This study is being conducted to evaluate the hemodynamic performance (i.e. flow of blood) in the legs using the new Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves.
- Trial name
- NCT05945186
- Testing
- Intermittent Pneumatic Compression (IPC)(Kendall SCD SmartFlow™ compression system with Cardinal Health Element compression sleeves)
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Cardinal Health
Proximal Junctional Kyphosis, Spino-pelvic Alignment
MSK Validation Study
Spinal posture and imbalance are known to be related to increased muscle expenditure, with narrow "cone of economy" of muscle effort defining the most comfortable postures.
- Conditions
- Proximal Junctional Kyphosis, Spino-pelvic Alignment, Thoracolumbar Spinal Fusion
- Trial name
- MSK (NCT04422288)
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- NuVasive
Coronary Artery Disease, Cardiovascular Diseases
Clinical Study for the Investigation and Validation of a Therapy Procedure for the Adjustment of Risk Factors in Patients With Coronary Heart Disease by Means of Digital Therapy Control
This study will test a controlled investigation of the efficacy and effectiveness of iATROS digital therapy management for risk factor adjustment in patients with coronary heart disease (CHD).
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Coronary Heart Disease, Ischemic Heart Disease
- Trial name
- ERKHA (NCT06091774)
- Testing
- CHD therapy through iATROS medical device
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- iATROS GmbH
Cow Milk Allergy
Symptoms Based Awareness Confirmation Study - CoMiSS Validation
The Cow's Milk-related Symptom Score (CoMiSS) tool has been developed to define a score to recognize cow's milk related symptoms in infants and young children.
- Trial name
- MOSAIC (NCT03004729)
- Testing
- CoMiSS questionnaire
- Where
- 10 sites in China
- Volunteers
- 300 people
- Sponsor
- Société des Produits Nestlé (SPN)
Allergic Conjunctivitis
Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC
This is a single center open study designed to determine the concentration of airborne birch pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen, during allergen exposures in the Alyatec…
- Trial name
- NCT04641130
- Testing
- Exposure to birch pollen in EEC
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Alyatec
Temporomandibular Disorder, Motor Imagery
Assessing Motor Imagery Ability of Tongue and Mouth in Subjects With and With no Temporomandibular Disorders
Temporomandibular disorder (TMD) is the symptomatic expression of a muscular or an articular impairment at the manducatory tract. TMD affects between 30 to 65% of the population with a higher prevalence for young women.
- Trial name
- TMIQ (NCT04102306)
- Testing
- reliability and validity construct of the TMIQ
- Where
- France
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Cabinet de Kinesitherapie SCM Saint-Alexandre
Pulse Oximetry
SpO2 Validation Study - Philips FAST 2024
Validation study to compare the accuracy of non-invasive Philips SpO2 sensors in detecting blood oxygen levels compared to invasive methods requiring a blood draw and lab analysis.
- Trial name
- FAST 2024 (NCT06484452)
- Testing
- No Intervention
- Where
- United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Hypoxia
In Vivo Pulse Oximeter Validation Study
The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults.
- Trial name
- NCT05873335
- Testing
- Mixtures of nitrogen, air, and carbon dioxide
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
Bipolar Disorder I or II
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
A non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
- Trial name
- NCT00259272
- Testing
- olanzapine
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- Eli Lilly and Company
Lymphoma, Non-Hodgkin
Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade…
- Trial name
- RIT-II-001 (NCT01224821)
- Testing
- Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Critical Illness
NIBP Validation Study
The purpose of this study is to compare measurements of blood pressure (BP) between the Philips non-invasive blood pressure (NIBP) system (including NIBP cuff and portable patient monitor) and invasive radial for Subject Group 2…
- Trial name
- NCT05673408
- Testing
- Philips IntelliVue X3 Patient Monitor
- Where
- 5 sites in United States
- Volunteers
- 189 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Atrial Fibrillation
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
- Trial name
- NCT04380415
- Testing
- Single lead ambulatory ECG patch
- Where
- 2 sites in United States
- Volunteers
- 450,000 people, healthy volunteers welcome
- Sponsor
- Fitbit LLC
Malignant Skin Melanoma T0, Basal Cell Carcinoma
DERM US and EU Validation Study
This study aims establish the effectiveness of Image Analysing Algorithm (DERM) to identify melanoma, Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) when used to analyse dermoscopic images of skin lesions within the…
- Conditions
- Malignant Skin Melanoma T0, Basal Cell Carcinoma, Squamous Cell Carcinoma
- Trial name
- NCT05126173
- Testing
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Where
- 16 sites in United States, Italy
- Volunteers
- 1,111 people
- Sponsor
- Skin Analytics Limited
Obstetric Complication, GYN Disorders
OB-GYN Clinical Validation Study
This is a single-site study evaluating obstetrics and gynecology exam imaging quality by expert users.
- Trial name
- NCT06449872
- Testing
- Obstetrics and Gynecology clinical applications for ultrasound diagnostic systems
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- EchoNous Inc.
Lifestyle-related Condition, Nutrient; Excess
Dietary Quality Photo Navigation (DQPN) Preliminary Validation Study
The purpose of this research project is to conduct a preliminary validation study of the Diet Quality Photo Navigation (DQPN) method of dietary intake assessment.
- Trial name
- NCT03661931
- Testing
- DQPN Validation
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Boston Heart Diagnostics
Ventricular Tachyarrhythmias
Initial Chronic Human Validation Study: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System
Primary objective is to evaluate the safety and performance of the implanted Subcutaneous implantable cardioverter defibrillator (S-ICD) system.
- Trial name
- Chronic II (NCT00853645)
- Testing
- Subcutaneous Implantable Defibrillator (S-ICD) System
- Where
- 2 sites in New Zealand
- Volunteers
- 6 people
- Sponsor
- Boston Scientific Corporation
Healthy, Hypoxia
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Oxygen Saturation
The purpose of this study is to evaluate the SpO2 accuracy and performance of the Norbert Device during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-oximetry for SpO2…
- Trial name
- NCT05685654
- Testing
- Norbert Device
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Norbert Health