Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LunulaLaser OTC | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LunulaLaser OTC | Device | The LunulaLaser™ OTC is a nonthermal and non-invasive procedure designed to restore the growth of clear, healthy nails in clients with onychomycosis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Each study session was completed on a single day, for up to 120 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- None
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erchonia Corporation | Melbourne | Florida | 32904 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LunulaLaser OTC | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LunulaLaser OTC | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Number of subject users that were defined as a study "pass". | Posted | Number | participants | Each study session was completed on a single day, for up to 120 minutes |
|
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LunulaLaser OTC | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Travis Sammons | Erchonia Corporation | 864-531-0064 | tsammons@erchonia.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 4, 2021 | Feb 8, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
Not provided
Not provided
Not provided
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |