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NCT Number: NCT07414810

Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

2 week–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adult Cystic Fibrosis Clinic, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • History of skin disorders (eczema, psoriasis, etc.) that could prevent sweat testing on the forearms

Treatment and study plan

micro Sweat Test Patch (mSTP)

Device

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.

Other names: Novel sweat test sensor

Sweat Testing using SOC

Diagnostic Test

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.

Other names: Pilocarpine Iontophoresis

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Visual Erythema Assessment Scale

    Time frame: Immediately after patch removal

    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.

  2. Pain Score

    Time frame: Up to 2 hours post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lokesh Guglani, MD

CONTACT

[email protected]

404-785-7856

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Georgia Institute of Technology
  • The Consortium for Technology & Innovation in Pediatrics (CTIP)

Registry information

Acronym: SWEAT CF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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