Actively Recruiting
Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2025-02-20
150
Participants Needed
1
Research Sites
230 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers
- Carriers of cystic fibrosis (e.g., parents of people with cystic fibrosis)
- People with known cystic fibrosis or classified as cystic fibrosis related disease
You will not qualify if you...
- Any individual with skin lesions affecting the measurement site
- Pregnant or breastfeeding women
- Participants with temporary or definitive disabilities to give consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
Research Team
S
Sophie Gohy, MD,PhD
CONTACT
A
Angélique Mottais
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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