Informations générales
  • Catégorie de maladie Autre (BASEC)
  • État du recrutement recrutement terminé (BASEC/ICTRP)
  • Lieu de l’étude
    Berne
    (BASEC)
  • Responsable de l'étude Lukas Jörg aip@insel.ch (BASEC)
  • Source(s) de données BASEC: Importé de 03.07.2025 ICTRP: N/A
  • Date de mise à jour 03.07.2025 15:55
HumRes65688 | SNCTP000006033 | BASEC2024-D0059

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

  • Catégorie de maladie Autre (BASEC)
  • État du recrutement recrutement terminé (BASEC/ICTRP)
  • Lieu de l’étude
    Berne
    (BASEC)
  • Responsable de l'étude Lukas Jörg aip@insel.ch (BASEC)
  • Source(s) de données BASEC: Importé de 03.07.2025 ICTRP: N/A
  • Date de mise à jour 03.07.2025 15:55

Résumé de l'étude

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)

Intervention étudiée

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)

Maladie en cours d'investigation

Skin testing for clarifying hay fever/aeroallergies and food allergies

(BASEC)

Critères de participation
Routine allergy clarification with the performance of prick tests Minimum age 18 years No intake of antihistamines in the last 5 days (BASEC)

Critères d'exclusion
Patients under anti-allergic medications. Patients with skin diseases, especially eczema in the arm area. Patients with more than 40 prick tests. (BASEC)

Lieu de l’étude

Berne

(BASEC)

non disponible

Sponsor

Inselspital Bern

(BASEC)

Contact pour plus d'informations sur l'étude

Personne de contact en Suisse

Lukas Jörg

+41 31 632 22 69

aip@insel.ch

Inselspital Bern

(BASEC)

Informations scientifiques

non disponible

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique de Berne

(BASEC)

Date d'approbation du comité d'éthique

08.08.2024

(BASEC)


Identifiant de l'essai ICTRP
non disponible

Titre officiel (approuvé par le comité d'éthique)
Sensitivity and specificity study of electromedical device Nexkin DSPT and manual measurement of hives in allergy skin prick tests (BASEC)

Titre académique
non disponible

Titre public
non disponible

Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
non disponible

Plan de l'étude
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Critères d'inclusion/exclusion
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non disponible

Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai

Résumé des résultats

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Lien vers les résultats dans le registre primaire

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