Tests a new sweat device in people with, carriers of, and without cystic fibrosis
Tests a new sweat-based device in healthy people, carriers, and people with cystic fibrosis.
Plain-language title generated from the registry record
Registry title: Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
Key facts
- Where
- Brussels, BelgiumSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy volunteers, carriers of cystic fibrosis (for example parents of people with cystic fibrosis), and people with known cystic fibrosis or a related disease. It tests a new sweat test device.
- Sex
- All sexes can join.
- Disease stage
- People with known cystic fibrosis or a disease classed as cystic fibrosis related disease. Healthy people and carriers can also join.
Main reasons for not taking part
- Skin lesions at the place where the test is measured
- Pregnant or breastfeeding women
- Temporary or permanent disability that prevents giving consent
Read by machine on 12 November 2026.
Where in Belgium
- Cliniques universitaires Saint-LucBrussels, BelgiumContact: Sophie GohyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Trial code
- NCT06836453
- Record updated
- 20 February 2025
- Original description
This is a clinical study to evaluate a new medical system used to perform a sweat secretion-based test for the diagnosis of cystic fibrosis.Read full original descriptionShow less
Evaluation of New System for β-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
This is a clinical study to evaluate a new medical system used to perform a sweat secretion-based test for the diagnosis of cystic fibrosis.
This clinical study will involve around 150 individuals in Belgium, including 50 healthy individuals, 50 carriers and 50 patients with cystic fibrosis.
The primary objective is to implement a new system for diagnosing cystic fibrosis according to their response to the beta-adrenergic test.
First session (50 minutes):
1. Left arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then bubble test. 2. right arm: Iontophoresis using the Macroduct for the cholinergic and β-adrenergic stimulation (2 iontophoresis), then evaporimetry.
Second session (50 minutes):
1. Left arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the beta-adrenergic stimulation, then bubble test. 2. Right arm: Iontophoresis using the Macroduct for the cholinergic and intradermal injection for the beta-adrenergic stimulation, then evaporimetry.
The secondary objectives of this clinical research are:
* Determining the best mode of administration for beta-adrenergic stimulation * Assessing the best quantification of sweat secretion * Comparing the response of the control group and the carrier group * Evaluating the stratification of people with cystic fibrosis according to CFTR dysfunction
The test consists of 5 steps:
1. sweat stimulation by cholinergic pathway 2. sweat secretion quantification 3. cystic fibrosis specific stimulation: beta-adrenergic pathway 4. sweat secretion quantification 5. analysis Both techniques of sweat stimulation and secretion quantification will be performed and compared to each other. Each participants will therefore have 2 sessions on both arms, with a minimum of one hour between the two sessions.
At each stimulation steps (step 1 to 3), the pain level during the test will be evaluated by self assessment in adults with Visual Analog Scale and children 2 to 6 years old with Faces Pain Scale - Revised or a hetero-assessment of pain for children less than 2 years old with douleur aigue du nouveau-ne scale.
Inclusion: Healthy volunteers; carriers (e.g. parents of people with cystic fibrosis); people with known cystic fibrosis or classified as cystic fibrosis related disease.
Exclusion: Any individual with skin lesions affecting the measurement site; pregnant or breastfeeding women; participants with temporary or definitive disabilities to give consent.