A new sweat sensor device for diagnosing cystic fibrosis
Skin-interfaced Colorimetric Bifluidic Sweat Sensor Device for the Diagnosis of Cystic Fibrosis (CF)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05998629 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a known diagnosis of cystic fibrosis or healthy volunteers.
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.
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 performed: Previous studies have shown promise in using point-of-care skin-interfaced microfluidic systems for similar diagnostic purposes, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Hershey, Pennsylvania
- Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Robert Vender
- Email: rvender@pennstatehealth.psu.edu
- Phone: 17175316525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.