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

NCT05284565 | Completed

• 1 other identifier: NEXKIN01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergy

Keywords

skin prick test; allergy; skin testing; SPT; 3D imaging; allergy testing; allergy test reading; automatic measurement

Outcome Measures

Primary Outcomes (1)

• Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure

  Fifteen minutes after the punctures have been performed, a double reading of the forearm shall be taken with the device. The first reading will be stored for later analysis, and the second reading will be used afterwards. The healthcare professional will then perform the manual reading and generate the manual result sheet as is standard practice. The health professional visually examines the forearm and compares his observation with the identification presented by the device. The result of the identifications made by the device as well as the interactions of the healthcare professional on the screen shall be recorded on the device. Diameter measurements are measured in millimetres (mm) and area measurements are measured in square millimetres (mm2).

  5 minutes

Secondary Outcomes (2)

• Test-retest reliability of device reading.

  5 minutes

• Variability in measurements of histamine wheals made by different health professionals.

  5 minutes

Study Arms (1)

Results of reading

OTHER

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.

Device: Reading of the skin prick allergy test

Interventions

Reading of the skin prick allergy test 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.

Results of reading

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are to be tested with a prick number greater than 40.
• 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.
• Patients who have taken an antihistamine within the previous 3 days.
• Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
• Patients who suffer severe atopic dermatitis affecting the forearms.
• Patients with dermographism.
• Patients who are to undergo intradermal testing.
• Pregnant women or women suspected of pregnancy.

Sponsors & Collaborators

• INNOPRICK SL: lead
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator

Study Sites (1)

Clinica Universidad de Navarra, Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (3)

• Justo X, Diaz I, Gil JJ, Gastaminza G. Medical Device for Automated Prick Test Reading. IEEE J Biomed Health Inform. 2018 May;22(3):895-903. doi: 10.1109/JBHI.2017.2680840. Epub 2017 Mar 9.

  PMID: 28362597 BACKGROUND

• Justo X, Diaz I, Gil JJ, Gastaminza G. Prick test: evolution towards automated reading. Allergy. 2016 Aug;71(8):1095-102. doi: 10.1111/all.12921. Epub 2016 May 20.

  PMID: 27100940 BACKGROUND

• Morales-Palacios MP, Nunez-Cordoba JM, Tejero E, Matellanes O, Quan PL, Carvallo A, Sanchez-Fernandez S, Urtasun M, Larrea C, Iniguez MT, Gimenez R, Goikoetxea MJ, D'Amelio CM, Ferrer M, Gastaminza G. Reliability of a novel electro-medical device for wheal size measurement in allergy skin testing: An exploratory clinical trial. Allergy. 2023 Jan;78(1):299-301. doi: 10.1111/all.15474. Epub 2022 Aug 20. No abstract available.

  PMID: 35950712 BACKGROUND

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Gabriel Gastaminza Lasarte, Dr.

  Clinica Universidad de Navarra, Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 17, 2022
• Study Start: May 20, 2021
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)