Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: micro Sweat Test Patch (mSTP), Sweat Testing using SOC.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: 2 Weeks — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The current SOC sweat testing method, using pilocarpine iontophoresis and Macroduct collectors, results in inconsistent sweat production, leading to inadequate collection, delays in CF diagnosis, longer testing times, skin discomfort, and a risk of skin burns. It requires trained personnel and expensive equipment, limiting patient access, and repeating sweat tests after inadequate collection causes delays in starting therapies and stress for parents. In developing countries where CF remains underdiagnosed, access to sweat testing is a major barrier, and the need for refrigeration of the pilogel discs adds cost.
There is an unmet clinical need to improve access to sweat testing worldwide without expensive supplies and laboratory equipment.
Interventions
- Device micro Sweat Test Patch (mSTP)
A novel sweat test method, using a device that includes a microneedle pilocarpine patch and a microchannel with a sweat chloride sensor. µSTP sweat testing device that operates without electrical current, eliminating the risk of burns and the need for specialized equipment. Like the SOC method, the µSTP stimulates sweating with pilocarpine nitrate and measures sweat chloride concentration but differs from the current method by: 1. Utilizing microneedles to painlessly and rapidly administer pi - Diagnostic test Sweat Testing using SOC
The study team will place two pilocarpine gel discs into the corresponding electrodes and place them on the participant's arm. The SOC method takes 5 minutes to induce sweating. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the study visit will be completed. For newborns undergoing evaluation for CF, the study t
Primary outcome measures
- Sweat Chloride Concentration using the sweat test sensor [Time frame: up to 30 minutes post-device placement]
- Sweat Chloride Concentration by SOC [Time frame: up to 45 minutes post-intervention]
Secondary outcome measures (2)
- Visual Erythema Assessment Scale [Time frame: Immediately after patch removal]
- Pain Score [Time frame: Up to 2 hours post-intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Adult Cystic Fibrosis Clinic — Atlanta
- Arthur M. Blank Hospital | Children's Healthcare of Atlanta — Atlanta
Identifiers
NCT: NCT07414810 · 2025P011870