Digital device for reading allergy skin prick tests
Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests
Insel Gruppe AG, University Hospital Bern · NCT06743737
This study is testing a new digital device to see if it can read allergy skin prick tests more accurately than the traditional manual method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06743737 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of a digital device, Nexkin DSPT, in reading skin prick tests (SPTs) for allergies. SPTs are commonly used to diagnose allergies but are traditionally performed manually, which can introduce variability and subjectivity in results. The study aims to automate and digitize the reading process, providing more consistent and objective results. Participants will undergo skin prick tests with various allergens, and the digital device will be compared to standard manual readings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who are scheduled to undergo skin prick tests for allergies and have not taken antihistamines in the last 5 days.
Not a fit: Patients with severe atopic dermatitis, dermographism, or those who have taken antihistamines recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and reliable allergy diagnoses for patients.
How similar studies have performed: While the use of digital devices in medical diagnostics is growing, this specific approach to automating skin prick test readings is relatively novel and has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bern
- Inselspital, Bern University Hospital, University of Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Elnaz Arjmand — Inselspital, Bern / sitem-Insel AG
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Allergy Skin Prick Test Reading