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

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

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 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.

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 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.

Sponsors & Collaborators

• Georgia Institute of Technology

  collaborator OTHER

• The Consortium for Technology & Innovation in Pediatrics (CTIP)

  collaborator UNKNOWN

• Emory University

  lead OTHER

Principal Investigators

• Lokesh Guglani, MD · Emory University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Weeks

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-31

Primary Completion

2027-07-31

Completion

2027-07-31

FDA Device

Yes

Countries

• United States

Study Locations