New device for sweat testing in cystic fibrosis patients
Evaluation of New System for β-adrenergic Sweat Test in the Context of Stratification of Patient With Cystic Fibrosis
This study is testing a new device that measures sweat to see if it can help doctors better diagnose cystic fibrosis in patients, healthy individuals, and carriers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06836453 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates a new medical system designed to perform a sweat secretion-based test for diagnosing cystic fibrosis (CF). It will involve approximately 150 participants, including healthy individuals, carriers, and patients with CF, who will undergo a series of iontophoresis sessions to assess their sweat response to beta-adrenergic stimulation. The primary goal is to improve the diagnostic accuracy for CF by implementing this innovative testing approach. The study aims to differentiate between healthy individuals, carriers, and those with CF based on their sweat chloride levels.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers, carriers of cystic fibrosis mutations, and individuals diagnosed with cystic fibrosis or related diseases.
Not a fit: Patients with skin lesions at the measurement site or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and reliable diagnostic methods for cystic fibrosis, improving patient stratification and management.
How similar studies have performed: While the beta-adrenergic sweat test approach is novel, previous studies have indicated potential for success in improving CF diagnosis through innovative testing methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Sophie Gohy — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study coordinator: Sophie Gohy, MD,PhD
- Email: sophie.gohy@uclouvain.be
- Phone: +32 2 764 80 64
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.