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NCT07414810
Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
Conditions: Cystic Fibrosis
Sex: All
Ages: 2 Weeks – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Emory University
Location: Adult Cystic Fibrosis Clinic Atlanta Georgia
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07414810). StuddyBuddy aggregates publicly available trial information.