Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2024-06-15
2026-01-07
Brief Summary
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Technical Transition: To overcome the limitations of conventional absorbent pads, such as contamination and evaporation, it is essential to develop flexible, wearable microfluidic devices that enable immediate collection and high-precision analysis.
Domestic and International Trends: While countries like the U.S. are already utilizing real-time IoT monitoring technologies in military and sports sectors, there is an urgent need in Korea to secure physiological data optimized for the Korean population and to establish a robust medical analysis system.
2\. Objectives To develop a skin-interfaced microfluidic platform integrated with a SERS biosensor for high-sensitivity, real-time detection of Sodium and Creatinine to monitor dehydration and renal health.
3\. Research Plan
1. Subject Selection: Recruit and obtain informed consent from patients visiting the hospital with renal disease (creatinine levels 1.5 mg/dL or higher).
2. Clinical Schedule: Conduct the clinical study on the subjects' scheduled routine blood test dates.
3. Patch Attachment: Apply the sweat collection patch and a control absorption pad to 1-2 body areas (e.g., center of the chest, forehead).
4. Sweat Induction: Induce sweating by having subjects wait in an electric thermal chamber for 30 minutes.
5. Absorption Pad Collection: For the control pads (which cannot collect time-series data), attach two initially and retrieve them during the early stages of sweat secretion.
6. Microfluidic Patch Collection: Measure the volume of sweat collected (\~100 uL per subject) to calculate sweat loss, then seal and transport to the laboratory.
7. Comparative Sample Processing: Measure the weight of absorption pads before/after use to determine fluid loss. Extract sweat samples (\~500 uL per subject) into micro-tubes for transport.
8. Contamination Control: Utilize dry ice and insulated coolers during transport to prevent sample degradation or contamination.
9. Quantitative Analysis \& Evaluation: Perform quantitative analysis of sodium and creatinine levels from both samples using the proposed SERS-based method and standard analytical tools (HPLC or LC-MS). Compare the changes in biomarkers and sweat loss over time to evaluate and summarize the hydration status and renal function patterns of each subject.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Experimental Group
Measurement of creatinine concentration in sweat using a microfluidic patch-based sweat sensor
Time-course changes in Sodium and Creatinine levels.
Time-course changes in Sodium and Creatinine levels.
Interventions
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Time-course changes in Sodium and Creatinine levels.
Time-course changes in Sodium and Creatinine levels.
Eligibility Criteria
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Inclusion Criteria
* Patients with renal disease and a blood (serum) creatinine level of 1.5 mg/dL or higher
Exclusion Criteria
* Subjects with a medical history of skin allergies related to patches/adhesives
19 Years
ALL
No
Sponsors
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Korea University
OTHER
Responsible Party
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LEE SUNGHO
Professor
Locations
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Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Countries
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Other Identifiers
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2024AN0368
Identifier Type: -
Identifier Source: org_study_id
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