Actively Recruiting
Study of the Nexkin DSPT Digital Device Compared to Manual Measurement for Allergy Skin Prick Test Reading
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
Researchers are evaluating a digital device called Nexkin DSPT designed to read skin prick tests (SPTs) used for diagnosing allergies. SPTs are commonly used, simple, safe, and quick tests that help identify sensitization to allergens in conditions like bronchial asthma, rhinoconjunctivitis, food or drug allergies, and anaphylaxis. This study aims to validate the clinical usefulness of Nexkin DSPT by comparing its sensitivity and specificity with the standard manual method for measuring wheals from these tests. The study involves using the Nexkin DSPT device, which optically measures the size of wheals from skin prick tests performed on patients. These tests involve applying allergen panels to the skin and measuring the reaction. Both manual and digital measurements of positive (histamine) and negative (NaCl) controls are taken to assess the device's accuracy. The digital method aims to reduce variability, subjectivity, and manual effort, providing quantitative results and faster processing compared to the traditional manual method. Participants will undergo skin prick testing with allergen panels, and measurements of wheal sizes will be recorded by healthcare professionals using both manual and digital methods at enrollment. The outcomes include the size of wheals for positive and negative controls measured by both techniques. The study monitors for adherence to antihistamine restrictions prior to testing and excludes certain patient groups to ensure accurate results. This evaluation seeks to improve allergy diagnosis by potentially offering more consistent and efficient test readings.
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
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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
Frequently Asked Questions
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