Clinical trials: VALİDİTY
Measure Accuracy of Respiratory Rate
Respiratory Rate Validation Study
The purpose of this study is to conduct a Respiratory Rate accuracy validation on pediatrics population comparing the Gabi SmartCare Gabi Band to the Reference, an FDA cleared End Tidal Carbon Dioxide monitor (GE Datex- Ohmeda)…
- Trial name
- NCT05856422
- Testing
- Respiratory rate measure based on PPG
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
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
Infiltration of Peripheral IV Therapy
ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
- Trial name
- NCT02120443
- Testing
- ivWatch Model 400
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- ivWatch, LLC
Dry Eye Syndromes
Validation of TearLab Osmometer - Human Factor Usability Report
The objective of this study is to validate the performance of the OcuSense TearLab™ osmolarity test when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from…
- Trial name
- NCT00731484
- Where
- 3 sites in United States
- Volunteers
- 233 people, healthy volunteers welcome
- Sponsor
- TearLab Corporation
SARS-CoV-2, Influenza A
Clinical Validation of the LumiraDx SARS-CoV-2 & Flu A/B Combo Test
This is a prospective multicenter study conducted to evaluate the performance of the LumiraDx SARS-CoV-2 \& Flu A/B tests at point of care sites.
- Conditions
- SARS-CoV-2, Influenza A, Influenza B, Asymptomatic COVID-19
- Trial name
- ITAP1489 (NCT05787444)
- Testing
- LumiraDx SARS-CoV-2 & Flu A/B
- Where
- United States
- Volunteers
- 1,081 people
- Sponsor
- LumiraDx UK Limited
Multiple Sclerosis
Validation of the BeCare Multiple Sclerosis Assessment App
This study involves data collection from use of the BeCare Link LLC mobile device app by subjects with Multiple Sclerosis.
- Trial name
- NCT04288011
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- BeCare Link LLC
Cardiovascular Diseases, Hypertension
Investigation and Validation of a Study Project on Digital Therapy Management of Patients With Arterial Hypertension
The purpose of this pilot study is to exploratively test the basic feasibility of a clinical trial for the controlled investigation of the efficacy and effectiveness of iATROS digital therapy management in the treatment of…
- Trial name
- eXPLORE (NCT05580068)
- Testing
- Hypertension therapy through iATROS medical device
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- iATROS GmbH
Metastatic Colorectal Cancer, RAS Wild-type
Validation of a New Prognostic Score for Adult Patients With RAS Wild-type mCRC Treated With Vectibix® and FOLFIRI or FOLFOX in First Line (VALIDATE)
A safety and efficacy study of first line therapy with Vectibix® in combination with FOLFIRI or FOLFOX to validate a prognostic score in adult patients with RAS wild-type metastatic colorectal cancer in a real world setting…
- Trial name
- VALIDATE (NCT03043950)
- Testing
- Panitumumab
- Where
- Germany
- Volunteers
- 647 people
- Sponsor
- iOMEDICO AG
Sepsis
Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
- Trial name
- NCT04414189
- Testing
- HostDx Sepsis
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Inflammatix
Dry Eye
Validation of Osmolarity System: Clinical Usability Study
Confirmatory trial to validate usability of a new portable osmolarity testing device.
- Trial name
- NCT03769324
- Testing
- Osmolarity Test
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- I-MED Pharma
SARS-COV2 Infection
Validation of HyperDetector for SARS-CoV-2
To evaluate the HyperDetector as a method to rapidly screen SARS-CoV-2 To determine the sensitivity and specificity of the screening assay performed on oral swab and saliva specimens, compared to a validated RT-PCR COVID-19…
- Trial name
- NCT05124496
- Testing
- Screening Device
- Where
- United States
- Volunteers
- 10,000 people, healthy volunteers welcome
- Sponsor
- HyperSpectral APD
Wound Infection
Biofilm Correlation and Validation
This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm.
- Trial name
- NCT05196880
- Testing
- MolecuLight DX Imaging Device
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- MolecuLight 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
Metastatic Prostate Cancer, CTC
Validation of the Prostate Cancer Assay - Beta+Pivotal
The Prostate Cancer Assay performance of Celsee Diagnostics circulating tumor cell (CTC) analysis system will be validated in patients diagnosed with metastatic prostate cancer.
- Trial name
- VPCA-B+PIV (NCT02742259)
- Testing
- Blood Draw
- Sponsor
- Celsee Diagnostics
Non-melanoma Skin Cancer
DERM NMSC Validation Study
This study aims to establish the effectiveness of an Artificial Intelligence (AI) algorithm (DERM) to determine the presence of Basal Cell Carcinoma (BCC) and Squamous Cell Carcinoma (SCC) and frequently observed benign…
- Trial name
- NCT04116983
- Testing
- Deep Ensemble for the Recognition of Malignancy (DERM)
- Where
- 3 sites in United Kingdom
- Volunteers
- 572 people
- Sponsor
- Skin Analytics Limited
Cancer Cachexia
Exploratory Trial of SAT-003 in Cancer Cachexia Patients With Discontinued Chemotherapy
This clinical trial aims to evaluate the feasibility of 'SAT-003' as well as its exploratory safety and efficacy in patients with cancer cachexia who have been diagnosed with solid tumors and have discontinued anticancer…
- Trial name
- NCT06476197
- Testing
- SAT-003
- Where
- South Korea
- Volunteers
- 15 people
- Sponsor
- S-Alpha Therapeutics, Inc.
Blood Pressure
Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
- Trial name
- NCT06574113
- Testing
- Perin Health Patch
- Where
- United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Perin Health Devices
Heart Failure
Nanowear Heart Failure Management Multi-sensor Algorithm
The NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which…
- Trial name
- Nanosense (NCT03719079)
- Testing
- SimpleSENSE
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Nanowear Inc.
Cancer
Entia Liberty: Accuracy and Precision
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers.
- Trial name
- NCT05025124
- Testing
- Entia Liberty
- Where
- United Kingdom
- Volunteers
- 530 people
- Sponsor
- Entia Ltd
Hepatocellular Carcinoma
Refinement and Validation of a Diagnostic Model (GAMAD) for Early Detection of Hepatocellular Carcinoma
Most hepatocellular carcinoma (HCC) cases were at advanced stage when diagnosis established. This study is intended to establish a clinical diagnostic model GAMAD for early-stage HCC and evaluate the diagnostic efficiency the…
- Trial name
- NCT05626985
- Testing
- GAMAD
- Where
- 3 sites in China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- Singlera Genomics Inc.