Evaluation of New Device for Beta-adrenergic Sweat Test in the Context of Stratification o
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
| Condition(s) | Cystic Fibrosis |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 Macrod |
| Who can participate | 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 |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Locations | Brussels, Belgium |
| Start date | 2025-01-01 |
| NCT ID | NCT06836453 |
| Official listing | https://clinicaltrials.gov/study/NCT06836453 |