Digital Device Reading Skin Prick Test

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergy Skin Prick Test Reading

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elnaz Arjmand

Role: PRINCIPAL_INVESTIGATOR

Inselspital, Bern / sitem-Insel AG

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inselspital, Bern University Hospital, University of Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lukas Jörg

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-D0059

Identifier Type: -

Identifier Source: org_study_id