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Completed

NCT Number: NCT07342387

Development of Microfluidic Patch-type Sweat Sensor

1. Background Value of Sweat: Sweat has gained significant attention as a key biomarker for diagnosing dehydration and renal dysfunction (e.g., uremia), as it contains essential indicators that reflect blood concentrations, such as electrolytes and metabolites (creatinine, urea).

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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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 19 years or older
  • Patients with renal disease and a blood (serum) creatinine level of 1.5 mg/dL or higher

Exclusion criteria

  • Subjects who do not provide consent to participate in this study
  • Subjects with a medical history of skin allergies related to patches/adhesives

Treatment and study plan

Time-course changes in Sodium and Creatinine levels.

Other

Time-course changes in Sodium and Creatinine levels.

Primary outcomes

  1. Time-course changes in Sodium and Creatinine levels.

    Time frame: enrollment day

    Measurement on the day of enrollment (Visit 1), followed by study termination

Sponsors and collaborators

Lead sponsor

Korea University

Other

Registry information

Official study title

Development of Microfluidic Patch-type Sweat Sensor Utilizing Surface-enhanced Raman Mechanism

Acronym: sweat sensor

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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