Informazioni generali
  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento completato (BASEC/ICTRP)
  • Luogo dello studio
    Berna
    (BASEC)
  • Responsabile dello studio Lukas Jörg aip@insel.ch (BASEC)
  • Fonte dati BASEC: Importato da 03.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 03.07.2025 15:55
HumRes65688 | SNCTP000006033 | BASEC2024-D0059

Automated skin test reading of prick tests with the skin test scanner Nexkin DSPT®

  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento completato (BASEC/ICTRP)
  • Luogo dello studio
    Berna
    (BASEC)
  • Responsabile dello studio Lukas Jörg aip@insel.ch (BASEC)
  • Fonte dati BASEC: Importato da 03.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 03.07.2025 15:55

Descrizione riassuntiva dello studio

In this research project, we want to investigate whether skin testing for clarifying, e.g., hay fever can also be evaluated automatically with a device with a high-resolution camera. We want to find out if this device allows for more accurate and faster evaluations than those performed by medical personnel. Prick tests are usually the examination of choice for clarifying respiratory and food allergies in order to prove allergies. Drops of allergy-triggering substances, such as pollen, are applied to the inner side of the forearm. Subsequently, each test site is superficially pierced with a tiny needle (lancet). After 15 minutes, the test can already be read. It is evaluated at which test sites a wheal and redness appear. In the last 20 years, little has changed in the execution. Both the application of the skin test and especially the subsequent evaluation and documentation are performed manually by medical personnel. An automatic reading with direct documentation in the digital clinic system would therefore be a significant simplification. We would like to find out what the advantages of an automated skin test reading device are. To this end, we also want to capture whether more accurate results and a faster evaluation are possible. We will only scan the forearm with the automated skin test reading device using a camera, which means an additional effort of about 3 minutes. No further consultations are necessary for this study.

(BASEC)

Intervento studiato

The study will be conducted as part of a regular allergy clarification, provided that prick tests are performed. Immediately after the reading of the prick tests by the medical personnel, the forearm will be additionally placed under a device with a camera, which will then automatically re-evaluate the skin test. The reading process takes less than 30 seconds, the switch to the device and positioning the arm requires a maximum additional effort of 3 minutes. No further appointments for the study are planned.

(BASEC)

Malattie studiate

Skin testing for clarifying hay fever/aeroallergies and food allergies

(BASEC)

Criteri di partecipazione
Routine allergy clarification with the performance of prick tests Minimum age 18 years No intake of antihistamines in the last 5 days (BASEC)

Criteri di esclusione
Patients under anti-allergic medications. Patients with skin diseases, especially eczema in the arm area. Patients with more than 40 prick tests. (BASEC)

Luogo dello studio

Berna

(BASEC)

non disponibile

Sponsor

Inselspital Bern

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

Lukas Jörg

+41 31 632 22 69

aip@insel.ch

Inselspital Bern

(BASEC)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione d'etica Berna

(BASEC)

Data di approvazione del comitato etico

08.08.2024

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Sensitivity and specificity study of electromedical device Nexkin DSPT and manual measurement of hives in allergy skin prick tests (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile