Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function (SWEAT CF)

Emory University

Status: Begins enrollment in 3 months

Conditions: Cystic Fibrosis

Treatments: Diagnostic Test: Sweat Testing using SOC; Device: micro Sweat Test Patch (mSTP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07414810

2025P011870

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 2 weeks to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Sweat testing using the standard of care

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Sweat Testing using SOC

Novel sweat test method

Experimental group

Description:

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.

Treatment:

Device: micro Sweat Test Patch (mSTP)