Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-24 @ 4:55 PM
NCT ID:
NCT03072550
Brief Summary:
Early feasibility 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.
Detailed Description:
The Sponsor has developed the RenewalNail™ plasma treatment system to topically treat fungal infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of both topical and oral therapies by combining the safety of a topical treatment with the efficacy of an oral treatment.
The primary objective of this early feasibility study is to evaluate the efficacy and safety of the RenewalNail™ plasma treatment system and Protocol in achieving mycological cure for the patient. 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. Two consecutive negative results will confirm the elimination of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will be no placebo arm in the study.
Secondary objectives include assessing if the treatment protocol results in clear nail growth for the patient over a 5-month interval.
Study:
NCT03072550
Study Brief:
Protocol Section:
NCT03072550