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

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT05998629
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels — DEVICE
    a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels
  • Standard of Care laboratory procedure for measurement of sweat — OTHER
    a skin-interface sweat measurement using a smart-watch type device

Study Details

Cystic fibrosis (CF) is a multisystem autosomal recessive inherited disease affecting approximately 75,000 individuals in USA. The sweat chloride (Cl) test remains the gold standard for diagnosis of CF but still has a number of limitations. The objectives of this study are: 1)To evaluate a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels as a potential low-cost but potentially accurate test to diagnoses cystic fibrosis (CF) and 2) To evaluate measurements of sweat chloride (Cl) using this same system in comparison to the standard clinical laboratory procedures routinely performed in the Clinical Laboratory at Penn State Health Milton S. Hershey Medical Center (PSH-HMC), Hershey, PA for assessment of the diagnosis of CF. This is a single institution study performed solely at PSH-HMC. Study participants will include 1) adults 18 years of age or older capable of providing signed and dated informed consent, 2) subjects with an established known diagnosis of cystic fibrosis (CF) or healthy volunteers, and 3) able to understand and speak English language. Exclusion criteria include: 1) any medical condition or disorder known to potentially interfere with accurate measurements of sweat chloride and 2) inability to understand and speak the English language. Cystic Fibrosis (CF) subjects will be identified from the population of eligible patients receiving medical care at Penn State Health- Milton S. Hershey Medical Center (PSH-HMC). Healthy donor volunteers will be recruited from various members of the PSH-HMC CF clinical care team, members of the Division of Allergy, Pulmonary and Critical Care (both faculty and trainees) at PSH-HMC, and PSU-University Park research team. The total projected number of combined enrolled subjects is 30. This is a single day single time study that will require approximately 60 minutes of subject participation. Potential risks include a) side effects from pilocarpine iontophoresis sweat test collection (pain, skin discomfort, blisters, rarely burns and b) loss of confidentiality. There will be no cost to subjects for study participation. There will be no reimbursement financially for study participation. There is no benefit to subjects for study participation. There is the potential benefit to medical science via identification of improved method to accurately measure sweat chloride for diagnosis of CF.

Key Dates

Start date
Jul 1, 2024
Status verified
Jan 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy control subjects experimental device
    a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for healthy control subjects
  • Active Comparator: Healthy control subjects standard of care
    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
  • Experimental: Cystic Fibrosis Subjects experimental device
    a skin-interfaced colorimetric bifluidic sweat device with two synchronous channels for cystic fibrosis subjects
  • Active Comparator: Cystic Fibrosis Subjects standard of care
    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

Primary Outcome Measure

Sweat chloride concentration using standard of care lab assessment [ Time Frame: Single point in time measurement 60 minutes after device attachment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033
Robert L Vender, MD
[email protected]
717-531-6525

Find similar trials in Hershey, PA

By research site
Penn State Milton S. Hershey Medical Center· Hershey, PA

Related Studies