Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518967
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Performance Study With the SiMoT System for in Vitro Diagnostic Tests
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analytical Performance Study of the Handheld Device Single-Molecule With a Large Transistor SiMoT for the Near-patient Testing of Biological Samples
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Advanced and performing technologies able to analyze specific biomarkers for the diagnosis prognosis and prediction as well as for the monitoring the personalized care and the evaluation of the therapeutic response to pathologies is currently considered extremely relevant Such technologies work only if molecular markers specific for a given pathology have been already validated This approach is considered of strategic importance for the health and well-being of citizens as well as for the sustainability of public spending Often however the analysis of the markers is carried out on tissues or fluids of the organs involved being hence quite invasive procedures In this scenario it is strategic to develop devices and platforms that allow the analysis of markers in a minimally invasive or non-invasive way through the analysis of peripheral biological fluids such as blood or urine The goal is to provide clinicians with the attackers advantage against a plethora of progressive diseases by mass-screening individuals who are affected by a disease long before symptoms appear or to allow the identification of those patients who have a high probability of recurring or responding to target-oriented pharmacological approaches This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor SiMoT device In the context of the present performance study the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system in the detection of exogenous biochemical molecules suitably selected to act as markers of interest
Detailed Description:
Advanced and performing technologies able to analyze specific biomarkers for the diagnosis prognosis and prediction as well as for the monitoring the personalized care and the evaluation of the therapeutic response to pathologies is currently considered extremely relevant Such technologies work only if molecular markers specific for a given pathology have been already validated This approach is considered of strategic importance for the health and well-being of citizens as well as for the sustainability of public spending Among the pathologies that will increasingly be monitored and treated thanks to enabling technologies for precision medicine tumors are certainly of particular importance Often however the analysis of the markers is carried out on tissues or fluids of the organs involved being hence quite invasive procedures In this scenario it is strategic to develop devices and platforms that allow the analysis of markers in a minimally invasive or non-invasive way through the analysis of peripheral biological fluids such as blood or urine The goal is to provide clinicians with the attackers advantage against a plethora of progressive diseases by mass-screening individuals who are affected by a disease long before symptoms appear or to allow the identification of those patients who have a high probability of recurring or responding to target-oriented pharmacological approaches
This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor SiMoT device The SiMoT device is an in vitro diagnostic - IVD system REGULATION EU 2017746 IVDR Art 2 point 2 that performs decentralized analyses near-patient testing such as for example patients home emergency unit ambulance composed of a palm reader completed by machine-learning artificial-intelligence software The system works through an accessory IVDR Art 2 point 4 represented by a disposable cartridge which determines the specific diagnostic application based on the molecular markers detected by the accessory In the context of the present performance study the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system in the detection of exogenous biochemical molecules suitably selected to act as markers of interest
The present performance study aims to verify the qualitative detection onoff of target molecules both proteins and nucleic acids with a single molecule threshold in 01 mL 10-20 M The threshold is established by the limit of identification LOI
Analytical performance will be evaluated according to standard statistical approaches such as analytical sensitivity analytical specificity trueness bias precision repeatability and reproducibility accuracy resulting from trueness and precision limits of detection and identification measurement range possible linearity threshold values including the determination of appropriate criteria for the collection and handling of samples and the control of known endogenous and exogenous interferences cross reactions
Risk evaluation Risk-to-Benefits rationale There are no identifiable physical psychic andor social risks for the patients enrolled in the study directly deriving from the procedures that will be followed for the enrollment and collection of the related data
This study pertains to the definition of the analytical performance of the Single-Sensor Single-Molecule with a large Transistor SiMoT device The SiMoT device is an in vitro diagnostic - IVD system REGULATION EU 2017746 IVDR Art 2 point 2 that performs decentralized analyses near-patient testing such as for example patients home emergency unit ambulance composed of a palm reader completed by machine-learning artificial-intelligence software The system works through an accessory IVDR Art 2 point 4 represented by a disposable cartridge which determines the specific diagnostic application based on the molecular markers detected by the accessory In the context of the present performance study the IVD SiMoT system will be equipped with an accessory-cartridge developed and produced without any diagnostic purpose but only to verify the analytical performance of the SiMoT system in the detection of exogenous biochemical molecules suitably selected to act as markers of interest
The present performance study aims to verify the qualitative detection onoff of target molecules both proteins and nucleic acids with a single molecule threshold in 01 mL 10-20 M The threshold is established by the limit of identification LOI
Analytical performance will be evaluated according to standard statistical approaches such as analytical sensitivity analytical specificity trueness bias precision repeatability and reproducibility accuracy resulting from trueness and precision limits of detection and identification measurement range possible linearity threshold values including the determination of appropriate criteria for the collection and handling of samples and the control of known endogenous and exogenous interferences cross reactions
Risk evaluation Risk-to-Benefits rationale There are no identifiable physical psychic andor social risks for the patients enrolled in the study directly deriving from the procedures that will be followed for the enrollment and collection of the related data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None