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Device

Sweat Sensor Device for Cystic Fibrosis

N/A
Recruiting
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up single point in time measurement 60 minutes after device attachment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to evaluate a new, potentially low-cost and accurate test for diagnosing cystic fibrosis (CF) by comparing it to the standard sweat chloride test. The study will involve adults with

Who is the study for?
This trial is for adults over 18 who can consent and speak English. It's open to those with a confirmed diagnosis of cystic fibrosis or healthy volunteers. People with conditions affecting sweat chloride measurements or non-English speakers cannot join.
What is being tested?
The study tests a new skin-interfaced device that measures sweat to diagnose cystic fibrosis, comparing its accuracy against standard lab procedures at Penn State Health Milton S. Hershey Medical Center.
What are the potential side effects?
Possible side effects include discomfort from the sweat test like pain, skin irritation, blisters, and rarely burns. There's also a risk of personal information being disclosed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~single point in time measurement 60 minutes after device attachment
This trial's timeline: 3 weeks for screening, Varies for treatment, and single point in time measurement 60 minutes after device attachment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sweat chloride concentration using standard of care lab assessment
Secondary study objectives
Sweat chloride concertation using skin-interfaced colorimetric device

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Healthy control subjects experimental deviceExperimental Treatment1 Intervention
a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for healthy control subjects
Group II: Cystic Fibrosis Subjects experimental deviceExperimental Treatment1 Intervention
a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for cystic fibrosis subjects
Group III: Cystic Fibrosis Subjects standard of careActive Control1 Intervention
standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for cystic fibrosis subjects
Group IV: Healthy control subjects standard of careActive Control1 Intervention
standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for measurement of sweat chloride concentrations for healthy control subjects

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Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
510 Previous Clinical Trials
2,796,444 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
25 Patients Enrolled for Cystic Fibrosis
~20 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
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