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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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
• Диагностический тест 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

Первичные конечные точки

• Sweat Chloride Concentration using the sweat test sensor [Срок оценки: up to 30 minutes post-device placement]
• Sweat Chloride Concentration by SOC [Срок оценки: up to 45 minutes post-intervention]

Вторичные конечные точки (2)

• Visual Erythema Assessment Scale [Срок оценки: Immediately after patch removal]
• Pain Score [Срок оценки: Up to 2 hours post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 2 центра

• Adult Cystic Fibrosis Clinic — Atlanta
• Arthur M. Blank Hospital | Children's Healthcare of Atlanta — Atlanta

Идентификаторы

NCT: NCT07414810 · 2025P011870

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗