Pilot Study of Swift Microwave Device for Onychomycosis (NCT05674747) | Clinical Trial Compass
CompletedPhase 1/2
Pilot Study of Swift Microwave Device for Onychomycosis
Canada39 participantsStarted 2023-03-27
Plain-language summary
This is an open, single site, pilot study in Canadian subjects diagnosed with mild to moderate toenail onychomycosis caused by dermatophytes. Three microwave treatment frequencies will be compared for efficacy and safety, evaluated by frequency of treatment-related adverse events, clinical improvement of a treated target toenail and inactivation/elimination of fungus in the target toenail. Outcomes will be evaluated at Month 6, Month 9 and Month 12 after initiation of treatments. Subjects not achieving 'temporary increase in clear nail' at Month 6 may receive extra microwave treatments to Month 9 or Month 12 to improve outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide written informed consent.
. Aged 18 years and above.
. Not Pregnant or breast feeding.
. Distal subungual onychomycosis (DSO) in a great toenail.
. One great toenail as a target for treatment having at least 20% involvement of the nail area and no more than 75% involvement of the nail area.
. Target toenail thickness 3mm or less.
. No area of infection \< 3mm from the proximal nail fold.
. Toenail for treatment with fungal infection confirmed by detection of a dermatophyte organism (i.e. Trichophyton rubrum).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients able to complete treatment regimen per protocol
Timeframe: Month 6
2
Proportion of Patients per group with 'Temporary Increase in Clear Nail'
. Nail changes that appear as parallel lines, small pinpoint depressions, brown spots, black or brown linear streaks, complete yellowing of all nails without textural change, green debris below the nail or notches in the nail margin ('non-onychomycotic dystrophy').
. Nails infected by rare fungal species or non-fungal organisms such as mould or bacteria
. "Spike" of onychomycosis extending to \<3mm from the eponychium (proximal nail fold) of the target toenail.
. Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
. Patients diagnosed with Diabetes Mellitus (types I and II).