Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC

Sponsors

Lead Sponsor: Erchonia Corporation

Source Erchonia Corporation
Brief Summary

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.

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.

Overall Status Recruiting
Start Date 2021-06-04
Completion Date 2023-06-01
Primary Completion Date 2023-06-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Human Factors Each study session was completed on a single day, for up to 120 minutes
Enrollment 15
Condition
Intervention

Intervention Type: Device

Intervention Name: LunulaLaser OTC

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

Arm Group Label: LunulaLaser OTC

Eligibility

Criteria:

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:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Contact

Last Name: Travis Sammons

Phone: 888.242.0571

Phone Ext.: 501

Email: [email protected]

Location
Facility: Status: Contact: Erchonia Corporation Travis Sammons 888-242-0571 501 [email protected]
Location Countries

United States

Verification Date

2022-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: LunulaLaser OTC

Type: Other

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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