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

Conditions

• Cystic Fibrosis

Eligibility Criteria

Sex

ALL

Age

2 Weeks - 90 Years

Healthy Volunteers

Not accepted

Interventions

• 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: 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.
• 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.

Study Details

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.

Key Dates

Start date

Aug 31, 2026

Status verified

Feb 2026

Primary completion

Jul 31, 2027

Completion

Jul 31, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Sweat testing using the standard of care
  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.
• Experimental: Novel sweat test method
  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.

Primary Outcome Measure

Sweat Chloride Concentration using the sweat test sensor [ Time Frame: up to 30 minutes post-device placement ]

Central Contacts

• Lokesh Guglani, MD
  404-785-7856
  [email protected]

Locations (2)

Find similar trials in Atlanta, GA

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