An interventional study of LunulaLaser OTC in Onychomycosis, sponsored by Erchonia Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Erchonia Corporation · Not applicable, Interventional, and Other
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.
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.
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's enrollment of 15 is below the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Erchonia Corporation is the lead sponsor of 48 studies on the registry; 2 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Human Factors
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".
Time frame: Each study session was completed on a single day, for up to 120 minutes
| Milestone | LunulaLaser OTC |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
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".
| participants | LunulaLaser OTC |
|---|---|
| Human Factors | 15 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LunulaLaser OTC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Categorical(Participants) | LunulaLaser OTC |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | LunulaLaser OTC |
|---|---|
| Mean | 40.13 ± 10.56 |
| Sex: Female, Male(Participants) | LunulaLaser OTC |
|---|---|
| Female | 11 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | LunulaLaser OTC |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 8 |
| More than one race | 2 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | LunulaLaser OTC |
|---|---|
| United States | 15 |
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Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Erchonia Corporation