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NCT06159348 · ClinicalTrials.gov registry record
Pilot Feasibility Study of a Novel Non-invasive Device for Diagnosis of Anemia
A clinical trial, sponsored by University of Utah.
- Completed
- Registry status
- 25
- Enrollment target
NCT06159348: Completed study, sponsored by University of Utah.
NCT06159348 is a clinical trial that has completed, run by University of Utah. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06159348 has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study 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 determinat
Primary Outcome
Each participant will have their hemoglobin measured using the ADA and blood analysis. These values will then be compared to measure the difference between the ADA values and the serum values.
Interventions
- DIAGNOSTIC_TEST Anemia Diagnostic Assistant (ADA)
- DIAGNOSTIC_TEST Serum hemoglobin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2023-12-12 |
What the finished NCT06159348 record still lists
NCT06159348 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Anemia Diagnostic Assistant (ADA) is the first listed.
NCT06159348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06159348 about?
NCT06159348 is a clinical study titled "Pilot Feasibility Study of a Novel Non-invasive Device for Diagnosis of Anemia". 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 faciliti...
What is the current status of trial NCT06159348?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2023-11-30. Estimated completion is 2023-12-12.
What interventions are being tested in trial NCT06159348?
The interventions under investigation include: Anemia Diagnostic Assistant (ADA) (DIAGNOSTIC_TEST), Serum hemoglobin (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06159348?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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