Actively Recruiting

Age: 18Years +
All Genders
ID06743737

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Inselspital, Bern University Hospital, University of Bern

Bern, Switzerland, 3010

Actively Recruiting

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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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