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

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-20

Study Completion Date

2021-07-27

Brief Summary

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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.

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Detailed Description

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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

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Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study will prospectively include patients attending the Allergology Department, after signing an informed consent form and a data protection clause.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Results of reading

All patients who were prick tested and accepted to participate in the study, were prospectively included in the study in only one arm. All of their tests were read by the device and the manual procedure.

Group Type OTHER

Reading of the skin prick allergy test

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patient to be tested with aeroallergen and/or food battery prick tests.
2. Patient over 12 years of age.
3. Patient, or his/her representative, who has given consent to participate in the study.
4. Patient who has not taken an antihistamine for more than 3 days.
5. Women of childbearing age who, at the time of taking the clinical history, declare that they are not pregnant.

Exclusion Criteria

1. Patients who are to be tested with a prick number greater than 40.
2. Patients who are to be tested with a prick number less than 40, but for whom it is necessary to place more than two rows of allergens in at least one of the arms.
3. Patients who have taken an antihistamine within the previous 3 days.
4. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
5. Patients who suffer severe atopic dermatitis affecting the forearms.
6. Patients with dermographism.
7. Patients who are to undergo intradermal testing.
8. Pregnant women or women suspected of pregnancy.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No