Trials / Withdrawn
WithdrawnNCT04442932
abioSCOPE IgE Assay to Aid in the Diagnosis of Allergies
Validation of the abioSCOPE Device With an IgE Test Panel: Clinical Sensitivity and Specificity Study
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Abionic SA · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Blood Collection | K3-EDTA venous whole blood 9 mL 1 venous draw |
Timeline
- Start date
- 2020-11-15
- Primary completion
- 2020-12-31
- Completion
- 2021-03-15
- First posted
- 2020-06-23
- Last updated
- 2020-10-05
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04442932. Inclusion in this directory is not an endorsement.