Human Factors Testing for OTC Use of the Erchonia® LunulaLaser
Human Factors Validation Testing for Over-the-Counter Use of the Erchonia® LunulaLaser™ OTC
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Melbourne, Florida, United States, 32904
- Erchonia Corporation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: LunulaLaser OTC
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.
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The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Human Factors
Time Frame: Each study session was completed on a single day, for up to 120 minutes
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The outcome measure identifies the number of subject users that were defined as a study "pass". A subject user is determined a study 'pass if the subject satisfactorily completes both the device setup and treatment procedure. If the subject user does not satisfactorily complete either one or both of device setup and/or treatment procedure the subject will be determined a study "fail". |
Each study session was completed on a single day, for up to 120 minutes
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-FFS-OTC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.