Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function

NCT07414810 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2025P011870
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cystic Fibrosis

Keywords

Sweat Test Device; Microneedle; Sensor; Pilocarpine; Micro Sweat Test Patch (mSTP)

Outcome Measures

Primary Outcomes (2)

• Sweat Chloride Concentration using the sweat test sensor

  Sweat chloride concentration by the µSTP will be assessed and measured using the sweat test sensor.

  up to 30 minutes post-device placement

• Sweat Chloride Concentration by SOC

  Sweat chloride concentrations will be measured using the standard-of-care method, using pilocarpine iontophoresis. The collected sweat samples will be sent for analysis of the chloride concentration. The results from the same participant will be compared to the measurements made with the µSTP device.

  up to 45 minutes post-intervention

Secondary Outcomes (2)

• Visual Erythema Assessment Scale

  Immediately after patch removal

• Pain Score

  Up to 2 hours post-intervention

Study Arms (2)

Sweat testing using the standard of care

ACTIVE COMPARATOR

For the SOC method, the forearm will be cleaned with alcohol and then cleaned with deionized (DI) water. The study team will then place two pilocarpine gel discs into the corresponding electrodes and place them on the subject's arm. The SOC method takes 5 minutes to induce sweating using iontophoresis. 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 sweat will be extracted from the collection device for analysis in the clinical lab using a chloridometer.

Diagnostic Test: Sweat Testing using SOC

Novel sweat test method

EXPERIMENTAL

Participants will have the micro Sweat Test Patch (µSTP) placed on the forearm after cleaning with an alcohol pad for 20 minutes. After the stimulation phase, the collection of sweat will be automatically collected by the microfluidics channel on the µSTP, and the sensor will continuously read the sweat chloride value.

Device: micro Sweat Test Patch (mSTP)

Interventions

micro Sweat Test Patch (mSTP) DEVICE

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 pilocarpine to the skin (without the complexities and risks of iontophoresis) 2. Requiring only 0.5 µL of sweat to measure sweat chloride (instead of the 15 µL currently required) 3. Wirelessly communicating the result to a tablet or other device 4. Completing the POC measurement to provide immediate results without sending any samples to the laboratory.

Also known as: Novel sweat test sensor

Novel sweat test method

Sweat Testing using SOC DIAGNOSTIC_TEST

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 team will perform the µSTP method on their thigh instead of the forearm. Since newborns will undergo sweat testing for their clinical diagnosis, the study team will use the sweat data from SOC testing to minimize burden. The sweat chloride concentration will be assessed by a laboratory chloridometer.

Also known as: Pilocarpine Iontophoresis

Sweat testing using the standard of care

Eligibility Criteria

• Age: 2 Weeks - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of skin disorders (eczema, psoriasis, etc.) that could prevent sweat testing on the forearms

Sponsors & Collaborators

• Emory University: lead
• Georgia Institute of Technology: collaborator
• The Consortium for Technology & Innovation in Pediatrics (CTIP): collaborator

Study Sites (2)

Adult Cystic Fibrosis Clinic

Atlanta, Georgia, 30324, United States

Location

Arthur M. Blank Hospital | Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Lokesh Guglani, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lokesh Guglani, MD

CONTACT

404-785-7856; lokesh.guglani@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)