abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies (NCT04442932) | Clinical Trial Compass
WithdrawnNot Applicable
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
Stopped: Sponsor financial has been stopped.
United States0Started 2020-11-15
Plain-language summary
This is a multicenter, prospective, observational study designed to determine the clinical sensitivity and specificity of the Abionic IVD CAPSULE Allergic Asthma panel performed on Abionic's abioSCOPE device using K3-EDTA anticoagulated plasma samples from atopic and non-atopic pediatric and adult patients. Patients' sensitization determined with the abioSCOPE will be compared to the clinical assessment of allergy.
Who can participate
Age range6 Years
SexALL
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Inclusion criteria
✓. Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
✓. Male or female, ≥ 6 years of age.
✓. Consulting for signs and/or symptoms of IgE-mediated allergies to perennial allergens.
✓. Provide signed and dated written informed consent by patient or legally designated representative prior to any mandatory study-specific procedures, sample collection, or analysis. Assent will be obtained from pediatric patients who are ≥ 6 years of age and less than 18 years of age.
✓. Male or female, ≥ 6 years of age.
✓. Apparently healthy individuals who exhibit no signs/symptoms of IgE-mediated allergies including rhinitis, conjunctivitis, asthma, eczema, urticaria or food allergy symptoms upon exposure to animal danders, dust mites, cockroaches, pollens or food allergens (non-atopic).
Exclusion criteria
✕. Patient participating in another study that may influence test results.
✕. Subjects taking any of the following medications: antihistamines in the week preceding the consultation, systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
✕. On-going allergen immunotherapy or prior allergen immunotherapy within the prior 3 years.