NCT06836453 Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
| NCT ID | NCT06836453 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2029-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-01-01 with a primary completion date of 2029-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Healthy volunteers * carriers (e.g. parents of people with cystic fibrosis) * people with known cystic fibrosis or classified as cystic fibrosis related disease Exclusion Criteria: * Any individual with skin lesions affecting the measurement site * pregnant or breastfeeding women * participants with temporary or definitive disabilities to give consent
Contact & Investigator
Sophie Gohy
PRINCIPAL INVESTIGATOR
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Frequently Asked Questions
Who can join the NCT06836453 clinical trial?
This trial is open to participants of all sexes, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06836453 currently recruiting?
Yes, NCT06836453 is actively recruiting participants. Contact the research team at sophie.gohy@uclouvain.be for enrollment information.
Where is the NCT06836453 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06836453 clinical trial?
NCT06836453 is sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The principal investigator is Sophie Gohy at Cliniques universitaires Saint-Luc- Université Catholique de Louvain. The trial plans to enroll 150 participants.