Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06159348
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2023-11-28
Brief Title:
Pilot Feasibility Study of a Novel Non-invasive Device for Diagnosis of Anemia
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Pilot Feasibility Study of a Novel Non-invasive Device for Diagnosis of Anemia
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In low-resource areas of the world anemia screening relies on analyzing a blood sample and is generally carried out in health facilities Current anemia screening approaches have not yielded satisfactory results due to critical limitations including lack of a reliable access to laboratory facilities b reliable non-invasive out-of-hospital screening tools for community health-workers c integration of anemia data across health systems and d distinction between hemolytic and nutritional causes Currently available non-invasive tools have unacceptably low accuracy and cannot distinguish between nutritional and hemolytic etiologies
Prototype Anemia Diagnostic Assistant ADA
We have developed a prototype Anemia Diagnostic Assistant for non-invasive simultaneous detection of two markers of anemia blood hemoglobin and the End-Tidal carbon monoxide levels The device comprises an optical sensor module and ETCO breath sampling module
The unique and significant advantage of the instrument is its ability to detect independently two orthogonal variables that are required for differential diagnosis of the nutritional and hemolytic anemia
1 Hemoglobin concentration using a non-invasive diffuse reflectance spectroscopy Using high-fidelity 11 wave-length spectral sensor the device will provide optical quantification of hemoglobin levels Optical hemoglobin sensing using diffused reflectance spectroscopy is well known however using traditional spectrophotometry instrumentation is very costly and thus impractical for this project As a solution we propose to use a validated commercially-available high accuracy 11-wavelength sensor within the visual and near-infrared IR range of the spectrum The 11-wavelength spectrum will allow for sufficient accuracy in measuring the reflectance AND transmittance at isosbestic wavelengths on hemoglobin extinction curve as well as to compensate for the presence of melanin which is a major interferant in optical determination of hemoglobin concentration 9 The sensor was originally designed to collect data on the earlobe andor the fingertip Additional iterations include a sensor that straps around the wrist similar to a smartwatch Both versions of the device may be used in the study and both feature standard USB or Bluetooth connectivity to ubiquitous mobile Android an iOS-based mobile platform
2 End-tidal carbon monoxide Using a non-invasive probe placed in proximity to the nostrils the device will measure ETCO as a proxy measure of hemolysis ETCO measurement as a measure for the presence of hemolysis is well documented in the medical literature and is commonly used in newborns units as a screening method for the presence of hemolysis 7810 A positive finding presence of elevated levels of ETCO will then prompt a referral for further hospital testing
The objective of this study is to determine the hemoglobin and ETCO concentration in healthy volunteers using the prototype device and compare the results with the hemoglobin and ETCO concentrations obtained using standard of care devices and the CoSense system for the ETCO measurement
Prototype Anemia Diagnostic Assistant ADA
We have developed a prototype Anemia Diagnostic Assistant for non-invasive simultaneous detection of two markers of anemia blood hemoglobin and the End-Tidal carbon monoxide levels The device comprises an optical sensor module and ETCO breath sampling module
The unique and significant advantage of the instrument is its ability to detect independently two orthogonal variables that are required for differential diagnosis of the nutritional and hemolytic anemia
1 Hemoglobin concentration using a non-invasive diffuse reflectance spectroscopy Using high-fidelity 11 wave-length spectral sensor the device will provide optical quantification of hemoglobin levels Optical hemoglobin sensing using diffused reflectance spectroscopy is well known however using traditional spectrophotometry instrumentation is very costly and thus impractical for this project As a solution we propose to use a validated commercially-available high accuracy 11-wavelength sensor within the visual and near-infrared IR range of the spectrum The 11-wavelength spectrum will allow for sufficient accuracy in measuring the reflectance AND transmittance at isosbestic wavelengths on hemoglobin extinction curve as well as to compensate for the presence of melanin which is a major interferant in optical determination of hemoglobin concentration 9 The sensor was originally designed to collect data on the earlobe andor the fingertip Additional iterations include a sensor that straps around the wrist similar to a smartwatch Both versions of the device may be used in the study and both feature standard USB or Bluetooth connectivity to ubiquitous mobile Android an iOS-based mobile platform
2 End-tidal carbon monoxide Using a non-invasive probe placed in proximity to the nostrils the device will measure ETCO as a proxy measure of hemolysis ETCO measurement as a measure for the presence of hemolysis is well documented in the medical literature and is commonly used in newborns units as a screening method for the presence of hemolysis 7810 A positive finding presence of elevated levels of ETCO will then prompt a referral for further hospital testing
The objective of this study is to determine the hemoglobin and ETCO concentration in healthy volunteers using the prototype device and compare the results with the hemoglobin and ETCO concentrations obtained using standard of care devices and the CoSense system for the ETCO measurement
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None