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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07414810). StuddyBuddy aggregates publicly available trial information.