Diseases of the Genitourinary Systemsweat sensorNCT07342387
Development of Microfluidic Patch-type Sweat Sensor
A study testing Time-course changes in Sodium and Creatinine levels. in people with Diseases of the Genitourinary System, run by Korea University at 1 site in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diseases of the Genitourinary System
- What is being tested?
- Time-course changes in Sodium and Creatinine levels.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2024to 7 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 years or older
- Patients with renal disease and a blood (serum) creatinine level of 1.5 mg/dL or higher
Who cannot join
- Subjects who do not provide consent to participate in this study
- Subjects with a medical history of skin allergies related to patches/adhesives
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
About this study
Official title: Development of Microfluidic Patch-type Sweat Sensor Utilizing Surface-enhanced Raman Mechanism
- 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.
Read more
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.
- 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.
- Research Plan
- Subject Selection: Recruit and obtain informed consent from patients visiting the hospital with renal disease (creatinine levels 1.5 mg/dL or higher).
- Clinical Schedule: Conduct the clinical study on the subjects' scheduled routine blood test dates.
- Patch Attachment: Apply the sweat collection patch and a control absorption pad to 1-2 body areas (e.g., center of the chest, forehead).
- Sweat Induction: Induce sweating by having subjects wait in an electric thermal chamber for 30 minutes.
- 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.
- Microfluidic Patch Collection: Measure the volume of sweat collected (~100 uL per subject) to calculate sweat loss, then seal and transport to the laboratory.
- 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.
- Contamination Control: Utilize dry ice and insulated coolers during transport to prevent sample degradation or contamination.
- 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.
- Conditions
- Diseases of the Genitourinary System
- Being tested
- Time-course changes in Sodium and Creatinine levels.
- Medical subject headings
- Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-course changes in Sodium and Creatinine levels.Other
Time-course changes in Sodium and Creatinine levels.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Measurement of creatinine concentration in sweat using a microfluidic patch-based sweat sensor Receives: Other: Time-course changes in Sodium and Creatinine levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-course changes in Sodium and Creatinine levels.
Measurement on the day of enrollment (Visit 1), followed by study termination
Measured: enrollment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jun 2024
- Primary completion20 Dec 2024
- Study completion7 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diseases of the Genitourinary SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE SUNGHO, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342387
- Sponsor's protocol ID
- 2024AN0368
- Acronym
- sweat sensor
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Microfluidic Patch-type Sweat Sensor Utilizing Surface-enhanced Raman Mechanism
- ClinicalTrials.gov ID
- NCT07342387
- Acronym / sponsor ID
- sweat sensor / 2024AN0368
- Conditions
- Diseases of the Genitourinary System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 7 Jan 2026 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- Research Plan
- Subject Selection: Recruit and obtain informed consent from patients visiting the hospital with renal disease (creatinine levels 1.5 mg/dL or higher).
- Clinical Schedule: Conduct the clinical study on the subjects' scheduled routine blood test dates.
- Patch Attachment: Apply the sweat collection patch and a control absorption pad to 1-2 body areas (e.g., center of the chest, forehead).
- Sweat Induction: Induce sweating by having subjects wait in an electric thermal chamber for 30 minutes.
- 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.
- Microfluidic Patch Collection: Measure the volume of sweat collected (~100 uL per subject) to calculate sweat loss, then seal and transport to the laboratory.
- 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.
- Contamination Control: Utilize dry ice and insulated coolers during transport to prevent sample degradation or contamination.
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Time-course changes in Sodium and Creatinine levels.Measurement of creatinine concentration in sweat using a microfluidic patch-based sweat sensor |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 19 years or older
- Patients with renal disease and a blood (serum) creatinine level of 1.5 mg/dL or higher
Key exclusion criteria (2 listed)
- Subjects who do not provide consent to participate in this study
- Subjects with a medical history of skin allergies related to patches/adhesives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-course changes in Sodium and Creatinine levels.Time-course changes in Sodium and Creatinine levels. | Other | Experimental Group |
Primary outcome
Time-course changes in Sodium and Creatinine levels.
Time frame: enrollment day
Measurement on the day of enrollment (Visit 1), followed by study termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-course changes in Sodium and Creatinine levels. in people with Diseases of the Genitourinary System, run by Korea University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-course changes in Sodium and Creatinine levels. (time frame: enrollment day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.