Cystic FibrosisSWEAT CFNCT07414810
Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
A study testing micro Sweat Test Patch (mSTP) and Sweat Testing using SOC in people with Cystic Fibrosis, run by Emory University at 2 sites in United States.
Trial summary
This study is being done to test a device called micro Sweat Test Patch (mSTP or µSTP). The study team will compare the standard of care (SOC) method of sweat testing with a novel sweat test technique using an integrated micro Sweat Test Patch (µSTP) with microneedle assembly made out of Pilocarpine nitrate… Read more about this study
- Who is it for?
- Ages 2 weeks to 90 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- micro Sweat Test Patch (mSTP) and Sweat Testing using SOC
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 weeks to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 0-90 years old
- Signed a written informed consent
- Confirmed CF diagnosis via genetic test or elevated Immunoreactive Trypsinogen (IRT) level in newborn screen
Who cannot join
- History of skin disorders (eczema, psoriasis, etc.) that could prevent sweat testing on the forearms
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Adult Cystic Fibrosis Clinic
Atlanta, Georgia, 30324
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
This study is being done to test a device called micro Sweat Test Patch (mSTP or µSTP).
The study team will compare the standard of care (SOC) method of sweat testing with a novel sweat test technique using an integrated micro Sweat Test Patch (µSTP) with microneedle assembly made out of Pilocarpine nitrate, microfluidic channels, and a chloride sensor for point-of-care (POC) measurements of sweat chloride concentrations in newborns being evaluated for cystic fibrosis (CF) diagnosis and in pediatric and adult people with CF (pwCF).
Read more
The procedures involve performing a SOC sweat test (if they are not a neonate) and the novel sweat test developed by the research team.
Recruitment for the study will take place at Children's Healthcare of Atlanta and Emory Healthcare cystic fibrosis clinics.
Read the detailed description
The current SOC sweat testing method, using pilocarpine iontophoresis and Macroduct collectors, results in inconsistent sweat production, leading to inadequate collection, delays in CF diagnosis, longer testing times, skin discomfort, and a risk of skin burns. It requires trained personnel and expensive equipment, limiting patient access, and repeating sweat tests after inadequate collection causes delays in starting therapies and stress for parents. In developing countries where CF remains underdiagnosed, access to sweat testing is a major barrier, and the need for refrigeration of the pilogel discs adds cost.
There is an unmet clinical need to improve access to sweat testing worldwide without expensive supplies and laboratory equipment.
- Conditions
- Cystic Fibrosis
- Being tested
- micro Sweat Test Patch (mSTP), Sweat Testing using SOC
- Keywords
- Sweat Test Device, Microneedle, Sensor, Pilocarpine, Micro Sweat Test Patch (mSTP)
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro Sweat Test Patch (mSTP)Device
Also called Novel sweat test sensor
A novel sweat test method, using a device that includes a microneedle pilocarpine patch and a microchannel with a sweat chloride sensor.
µSTP sweat testing device that operates without electrical current, eliminating the risk of burns and the need for specialized equipment.
Like the SOC method, the µSTP stimulates sweating with pilocarpine nitrate and measures sweat chloride concentration but differs from the current method by:
- Utilizing microneedles to painlessly and rapidly administer pilocarpine to the skin (without the complexities and risks of iontophoresis)
- Requiring only 0.5 µL of sweat to measure sweat chloride (instead of the 15 µL currently required)
- Wirelessly communicating the result to a tablet or other device
- Completing the POC measurement to provide immediate results without sending any samples to the laboratory.
Sweat Testing using SOCDiagnostic test
Also called Pilocarpine Iontophoresis
The study team will place two pilocarpine gel discs into the corresponding electrodes and place them on the participant's arm.
The SOC method takes 5 minutes to induce sweating. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the study visit will be completed. For newborns undergoing evaluation for CF, the study team will perform the µSTP method on their thigh instead of the forearm. Since newborns will undergo sweat testing for their clinical diagnosis, the study team will use the sweat data from SOC testing to minimize burden.
The sweat chloride concentration will be assessed by a laboratory chloridometer.
| Study group | Role | What they receive |
|---|---|---|
| Sweat testing using the standard of care | Active comparator | For the SOC method, the forearm will be cleaned with alcohol and then cleaned with deionized (DI) water. The study team will then place two pilocarpine gel discs into the corresponding electrodes and place them on the subject's arm. The SOC method takes 5 minutes to induce sweating using iontophoresis. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the sweat will be extracted from the collection device for analysis in the clinical lab using a chloridometer. Receives: Diagnostic Test: Sweat Testing using SOC |
| Novel sweat test method | Experimental | Participants will have the micro Sweat Test Patch (µSTP) placed on the forearm after cleaning with an alcohol pad for 20 minutes. After the stimulation phase, the collection of sweat will be automatically collected by the microfluidics channel on the µSTP, and the sensor will continuously read the sweat chloride value. Receives: Device: micro Sweat Test Patch (mSTP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sweat Chloride Concentration using the sweat test sensor
Sweat chloride concentration by the µSTP will be assessed and measured using the sweat test sensor.
Measured: up to 30 minutes post-device placement
Sweat Chloride Concentration by SOC
Sweat chloride concentrations will be measured using the standard-of-care method, using pilocarpine iontophoresis. The collected sweat samples will be sent for analysis of the chloride concentration. The results from the same participant will be compared to the measurements made with the µSTP device.
Measured: up to 45 minutes post-intervention
Secondary outcomes (2)
Visual Erythema Assessment Scale
The µSTP application site will be photographed after patch removal, and the degree of skin erythema at the site of µSTP application will be scored by the study team member using the Visual Erythema Assessment Scale. The Visual Erythema Assessment Scale ranges from 0 (clear/no erythema) to 9 (severe/intense redness).
1-2: Trace/Very Mild - Barely perceptible redness; may require side-by-side comparison with unaffected skin to detect.
3-4: Mild/Faint - Distinct pinkness but lacks sharp borders; usually described as a "healthy glow" in facial assessments.
5-6: Moderate - Clear, definite redness that is easily recognized across a room; skin may begin to feel warm.
7-8: Severe/Bright - Intense, fiery red coloration; often accompanied by localized swelling (edema) or heat.
9: Very Severe - Deep purple or "beet-red" intensity; may involve blistering, skin erosion, or extreme tenderness.
Measured: Immediately after patch removal
Pain Score
Pain Score will be assessed using either the Wong-Baker FACES® Pain Rating Scale or the numeric pain rating scale (NPRS). Both instruments use a 0 to 10 rating range.
The Wong-Baker FACES® Pain Rating Scale is a validated tool used to help individuals (typically ages 3 years and older) communicate their level of pain by selecting one from six faces representing increasing pain intensity. The scale corresponds to values from 0 ("no hurt") to 10 ("hurts worst"), with higher values indicating greater pain.
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which participants select an integer from 0 to 10 that best reflects the intensity of their pain. A score of '0' indicates "no pain", and a score of '10' represents the "worst pain imaginable".
For both scales, scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Up to 2 hours post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Georgia Institute of Technology, The Consortium for Technology & Innovation in Pediatrics (CTIP)
- Responsible party
- Principal investigator, Lokesh Guglani, Emory University
- Investigators
- Lokesh Guglani, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414810
- Sponsor's protocol ID
- 2025P011870
- Acronym
- SWEAT CF
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
- ClinicalTrials.gov ID
- NCT07414810
- Acronym / sponsor ID
- SWEAT CF / 2025P011870
- Conditions
- Cystic Fibrosis
- Keywords
- Sweat Test Device, Microneedle, Sensor, Pilocarpine, Micro Sweat Test Patch (mSTP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Georgia Institute of Technology, The Consortium for Technology & Innovation in Pediatrics (CTIP)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 Feb 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.
This study is being done to test a device called micro Sweat Test Patch (mSTP or µSTP).
The study team will compare the standard of care (SOC) method of sweat testing with a novel sweat test technique using an integrated micro Sweat Test Patch (µSTP) with microneedle assembly made out of Pilocarpine nitrate, microfluidic channels, and a chloride sensor for point-of-care (POC) measurements of sweat chloride concentrations in newborns being evaluated for cystic fibrosis (CF) diagnosis and in pediatric and adult people with CF (pwCF).
The procedures involve performing a SOC sweat test (if they are not a neonate) and the novel sweat test developed by the research team.
Recruitment for the study will take place at Children's Healthcare of Atlanta and Emory Healthcare cystic fibrosis clinics.
Detailed description
The current SOC sweat testing method, using pilocarpine iontophoresis and Macroduct collectors, results in inconsistent sweat production, leading to inadequate collection, delays in CF diagnosis, longer testing times, skin discomfort, and a risk of skin burns. It requires trained personnel and expensive equipment, limiting patient access, and repeating sweat tests after inadequate collection causes delays in starting therapies and stress for parents. In developing countries where CF remains underdiagnosed, access to sweat testing is a major barrier, and the need for refrigeration of the pilogel discs adds cost.
There is an unmet clinical need to improve access to sweat testing worldwide without expensive supplies and laboratory equipment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sweat testing using the standard of care | Active comparator | Diagnostic Test: Sweat Testing using SOCFor the SOC method, the forearm will be cleaned with alcohol and then cleaned with deionized (DI) water. The study team will then place two pilocarpine gel discs into the corresponding electrodes and place them on the subject's arm. The SOC method takes 5 minutes to induce sweating using iontophoresis. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the sweat will be extracted from the collection device for analysis in the clinical lab using a chloridometer. |
| Novel sweat test method | Experimental | Device: micro Sweat Test Patch (mSTP)Participants will have the micro Sweat Test Patch (µSTP) placed on the forearm after cleaning with an alcohol pad for 20 minutes. After the stimulation phase, the collection of sweat will be automatically collected by the microfluidics channel on the µSTP, and the sensor will continuously read the sweat chloride value. |
Who may qualify
- Ages
- 2 weeks to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 0-90 years old
- Signed a written informed consent
- Confirmed CF diagnosis via genetic test or elevated Immunoreactive Trypsinogen (IRT) level in newborn screen
Key exclusion criteria (1 listed)
- History of skin disorders (eczema, psoriasis, etc.) that could prevent sweat testing on the forearms
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 |
|---|---|---|
| micro Sweat Test Patch (mSTP)Also: Novel sweat test sensorA novel sweat test method, using a device that includes a microneedle pilocarpine patch and a microchannel with a sweat chloride sensor. µSTP sweat testing device that operates without electrical current, eliminating the risk of burns and the need for specialized equipment. Like the SOC method, the µSTP stimulates sweating with pilocarpine nitrate and measures sweat chloride concentration but differs from the current method by: 1. Utilizing microneedles to painlessly and rapidly administer pilocarpine to the skin (without the complexities and risks of iontophoresis) 2. Requiring only 0.5 µL of sweat to measure sweat chloride (instead of the 15 µL currently required) 3. Wirelessly communicating the result to a tablet or other device 4. Completing the POC measurement to provide immediate results without sending any samples to the laboratory. | Device | Novel sweat test method |
| Sweat Testing using SOCAlso: Pilocarpine IontophoresisThe study team will place two pilocarpine gel discs into the corresponding electrodes and place them on the participant's arm. The SOC method takes 5 minutes to induce sweating. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the study visit will be completed. For newborns undergoing evaluation for CF, the study team will perform the µSTP method on their thigh instead of the forearm. Since newborns will undergo sweat testing for their clinical diagnosis, the study team will use the sweat data from SOC testing to minimize burden. The sweat chloride concentration will be assessed by a laboratory chloridometer. | Diagnostic test | Sweat testing using the standard of care |
Primary outcome
Sweat Chloride Concentration using the sweat test sensor
Time frame: up to 30 minutes post-device placement
Sweat chloride concentration by the µSTP will be assessed and measured using the sweat test sensor.
Sweat Chloride Concentration by SOC
Time frame: up to 45 minutes post-intervention
Sweat chloride concentrations will be measured using the standard-of-care method, using pilocarpine iontophoresis. The collected sweat samples will be sent for analysis of the chloride concentration. The results from the same participant will be compared to the measurements made with the µSTP device.
2 secondary outcomes
Visual Erythema Assessment Scale
Time frame: Immediately after patch removal
Pain Score
Time frame: Up to 2 hours post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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.
Lokesh Guglani, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing micro Sweat Test Patch (mSTP) and Sweat Testing using SOC in people with Cystic Fibrosis, run by Emory University at 2 sites in United States.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lokesh Guglani, MD (404-785-7856, lokesh.guglani@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sweat Chloride Concentration using the sweat test sensor (time frame: up to 30 minutes post-device placement). The study lists 2 primary outcomes in all. 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 27 Oct 2026.