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Clinical Trial Summary

A study to determine if a three-treatment protocol with the RenewalNail™ plasma treatment system over a week will result in mycological cure and/or clear nail growth on the treated hallux toe.


Clinical Trial Description

The purpose of this study is to assess the clinical feasibility of DeviceFarm, Inc.'s RenewalNail™ system and the treatment protocol that was developed based on extensive laboratory testing on human cadaver nails. The Protocol calls for three 45-minute treatments performed over a week to achieve mycological cure. Mycological cure will be assessed with two consecutive mycological culture tests done over a week following the third treatment. Two consecutive negative mycology culture results confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study. Clear nail growth will be documented and assessed by photography for 5 months after treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03216200
Study type Interventional
Source DeviceFarm, Inc.
Contact
Status Completed
Phase N/A
Start date July 7, 2017
Completion date July 10, 2018

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