Clinical Trial

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

Study acronym: SWEAT CF
Not Yet Recruiting
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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, 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.
Trial Details
NCT Number NCT07414810
Lead Sponsor Emory University
Collaborators: Georgia Institute of Technology, The Consortium for Technology & Innovation in Pediatrics (CTIP)
Conditions Cystic Fibrosis
Enrollment 300 participants
Start Date 2026-08
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-02-17