Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

A new sweat sensor device for diagnosing cystic fibrosis

Official title: Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)

Run by Milton S. Hershey Medical Center · NCT05998629 · Data updated 2026-11-12

This study is testing a new sweat sensor to see if it can make diagnosing cystic fibrosis easier and more accurate for both patients with the condition and healthy volunteers.

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment30 (estimated)
SponsorMilton S. Hershey Medical Center
Academic / other
Locations1 site (Hershey, Pennsylvania)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedDecember 1, 2026
Study endsDecember 1, 2026
Registry record updatedJanuary 9, 2026
Trial IDNCT05998629 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 and older with a known diagnosis of cystic fibrosis or healthy volunteers.

Probably not a fit

Patients with medical conditions that interfere with sweat chloride measurements or those who cannot understand or speak English may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a novel skin-interfaced colorimetric bifluidic sweat sensor designed to improve the diagnosis of cystic fibrosis (CF). The device aims to provide a low-cost and accurate alternative to the traditional sweat chloride test, which has limitations such as insufficient sweat volume and complexity in young patients. Participants will include adults with a known diagnosis of CF or healthy volunteers, and the device's performance will be compared to standard laboratory procedures at Penn State Health Milton S. Hershey Medical Center. The goal is to enhance the accuracy and accessibility of CF diagnosis through real-time sweat analysis.

Why it matters

Potential benefit: If successful, this device could provide a more reliable and accessible method for diagnosing cystic fibrosis.

How similar studies have gone: Previous studies have shown promise in using point-of-care skin-interfaced microfluidic systems for similar diagnostic purposes, indicating potential success for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* adults 18 years of age or older capable of providing signed and dated informed consent,
* subjects with an established known diagnosis of cystic fibrosis (CF) or healthy volunteers,
* able to understand and speak English language.

Exclusion Criteria:

* any medical condition or disorder known to potentially interfere with accurate measurements of sweat chloride
* inability to understand and speak the English language.

Where it's running

  • Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.