NCT06743737

Digital Device Reading Skin Prick Test

Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy and anaphylaxis. Together with the clinical history, SPTs allow to draw conclusions on allergies based on the sensitization pattern. Nevertheless, the technique itself has evolved very little and continues to be performed entirely manually. This has a few drawbacks that limit the utility of the tests, in many cases limiting them to a purely qualitative assessment. In comparison to standard practice (manual measurement), the digital skin test reading device Nexkin DSPT can provide the following benefits for project participants: Automates and digitizes the test reading, provides test results in digital format, reduces variability and subjectivity and greater consistency of diagnosis, reduces manual tasks allowing health professionals providing quantitative instead of qualitative results and avoiding potential human errors and allows a faster workflow, resulting in shorter patient visits. The aim of this study is to validate the clinical utility of the electromedical skin test reading device Nexkin DSPT regarding its use in allergology clinics for the reading of skin prick allergy tests. The overall purpose of the study is to determine the sensitivity and specificity of skin prick tests (SPT) performed using the current practice of the fully manual SPT procedure and those performed using the Nexkin SPT DSPT (digital) procedure and to compare the sensitivity and specificity of both methods.

Conditions

• Allergy Skin Prick Test Reading

Interventions

Type	Name	Description
DEVICE	Digital skin test reading device	The device to be studied measures optically the size of the wheals from skin tests (SPT) performed for the diagnosis of allergen sensitization.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

1 site across 1 country: Switzerland