Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Erchonia

Status: Completed

Conditions: Onychomycosis

Treatments: Device: LunulaLaser OTC

Study type: Interventional

Funder types: Industry

Identifiers

NCT05626270

R-FFS-OTC

Details and patient eligibility

About

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 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older.
• Male or female.
• Currently employed at a nail salon, beauty salon and/or spa, fitness 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, massage therapist etc.
• Voluntarily signed consent form.

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

LunulaLaser OTC

Other group

Description:

The user will be presented with the device in its intended packaging as if receiving it at their place of employment. No additional information, instruction or training will be provided by the Study Observer, or any other individual associated with the study. The user will be left to work out how to operate the Erchonia LunulaLaser™ OTC as independently and naturally as possible without interference or influence from the Study Observer. While the user will have received the instructional information in the packaging as in intended use, he or she will not be instructed to use any of the information. It will be up to the user as to if or how he or she chooses to use that information to set up operation of the device as would occur under actual conditions of intended use.

Treatment:

Device: LunulaLaser OTC