NCT05284565

Comparative Study of Skin Prick Allergy Test Measurements Between Current Manual Procedure and Nexkin DSPT Device

Concordance Between the Electromedical Device Nexkin DSPT and the Manual Procedure in the Measurement of Papules in Allergy Skin Testing

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: INNOPRICK SL · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Clinical trial with the aim to evaluate the level of agreement in wheal size measures in allergy skin prick testing (SPT) between the electro-medical device Nexkin DSPT® and the manual measurement procedure used in the daily practice.

Detailed description

The purpose of the trial is to evaluate the concordance of measurements obtained by the Nexkin DSPT device versus the measurements obtained manually. A prospective clinical trial study was conducted at Clínica Universidad de Navarra. SPT will be tested in the same way as during a routine visit, with the only difference being that the images of the arm required for the device to operate will be captured. Nexkin DSPT device is a non-invasive device, which does not perform the procedure of puncture and appearance of papules. The device is only used to read the test results. There is no risk to the patient or the healthcare professionals involved in capturing images with the device. Device does not provide a diagnosis and it is not a substitute for sound medical judgment. The study will prospectively include patients attending the allergy consultation (sample size calculated in 93 patients) with positive (histamine) and negative (saline solution) controls. Fifteen minutes later, two consecutive readings with the device and two manual readings were performed by two different nurses. The area of the histamine wheals was measured automatically by Nexkin DSPT and after the manual procedure measured manually by planimetry.

Conditions

• Allergy

Interventions

Type	Name	Description
DEVICE	Reading of the skin prick allergy test	A double reading of the forearm will be performed with the Nexkin DSPT device. Also, two healthcare professionals will perform, consecutively, the manual reading according to their usual practice. Nexkin DSPT device provides a semi-automatic wheal detection, presenting the user an initial set of potential wheals and information about them (as their measure). Healthcare professional can then discard, add and/or confirm wheals by visual validation, and add/edit wheal information. The device automates the test reading process, digitises the results, and quantifies.

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-07-27
• Completion: 2021-07-27
• First posted: 2022-03-17
• Last updated: 2023-04-24

Locations

1 site across 1 country: Spain