Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Overview

Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to understand the information contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and box labeling.

Full Title of Study: “Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2023

Detailed Description

This study is an uncontrolled simulated-use human factors validation testing design to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to understand the information contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and box labeling. The study design is comprehensive in scope and conducted in a manner such that the results will be able to be generalized to the actual intended user and client population under intended conditions of actual use and be adequately sensitive to capture use errors arising from either the user interface design and/or the instructional and informative materials. Study data will be collected in a manner that will facilitate analysis of the root causes of use errors or problems during the testing.

Interventions

  • Device: LunulaLaser OTC
    • The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.

Arms, Groups and Cohorts

  • Other: LunulaLaser OTC

Clinical Trial Outcome Measures

Primary Measures

  • Human Factors
    • Time Frame: Each study session was completed on a single day, for up to 120 minutes
    • A subject user in this study will be considered as either a study ‘pass’ or a study ‘fail,’ defined as follows: Study Pass: A subject user who satisfactorily completes both the device setup and treatment procedure will be determined a Study Pass. Study Fail: A subject user who does not satisfactorily complete either one or both of device setup and/or treatment procedure will be determined a Study Fail.

Participating in This Clinical Trial

Inclusion Criteria

  • 18 years or older. – Male or female. – Currently employed at a nail salon, beauty salon and/or spa, health and wellness spa, or the like. – In possession of qualification(s), current licensure(s), certification(s), and/or accreditation(s), as applicable, to perform their designated tasks at their place of employment, e.g., cosmetology degree, nail technician, esthetician, etc. – Voluntarily signed consent form. Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erchonia Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Travis Sammons, 888.242.0571, tsammons@erchonia.com

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