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Device

LunulaLaser OTC for Fungal Nail Infection

N/A

Waitlist Available

Research Sponsored by Erchonia Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each study session was completed on a single day, for up to 120 minutes

Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each study session was completed on a single day, for up to 120 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each study session was completed on a single day, for up to 120 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and each study session was completed on a single day, for up to 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Human Factors

Trial Design

1Treatment groups

Experimental Treatment

Group I: LunulaLaser OTCExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

LunulaLaser OTC

2021

N/A

~20

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Erchonia CorporationLead Sponsor

43 Previous Clinical Trials

1,984 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more openings for this research project?

"Affirmative. According to available information on clinicaltrials.gov, the trial started recruiting patients in June of 2021 and was last updated in November 2022. The study is looking for 15 participants from a single site."

Answered by AI

What is the current cap of participants for this trial?

"Affirmative. The information on clinicaltrials.gov implies that this medical trial is actively seeking participants, having been first posted on June 4th 2021 and last updated November 15 of 2022. Fifteen patients will be accepted at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

2021. "Human Factors Testing for OTC Use of the Erchonia® LunulaLaser". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05626270.