Actively Recruiting
Digital Device Reading Skin Prick Test
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-20
200
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
S
sitem-insel AG Bern
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Digital Device Reading Skin Prick Test
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who will undergo skin prick tests with panels of aeroallergens and/or foods
- Over 18 years of age
- The patient or their representative has given consent to participate in the study
- The patient must not have taken an antihistamine in the last 5 days
You will not qualify if you...
- Patients who are evaluated by more than 40 prick tests
- Patients who have taken an antihistamine within the previous 5 days
- Patients who are being treated with antidepressants or other drugs with an antihistamine effect
- Patients who suffer severe atopic dermatitis with forearm involvement
- Patients with dermographism
- Patients who are evaluated by intradermal testing
- Pregnant women or women suspected to be pregnant
- Vulnerable patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Inselspital, Bern University Hospital, University of Bern
Bern, Switzerland, 3010
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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