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Microwave Device
Microwave Treatment for Toenail Fungus
Phase 1 & 2
Recruiting
Led By Aditya Gupta, MD,PhD
Research Sponsored by Mediprobe Research Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 9, month 12
Awards & highlights
Study Summary
This trial compares microwave treatments for toenail fungus in Canadian patients. Safety, improvement & fungus inactivation/elimination will be measured over 12 months. Extra treatments may be given if improvement isn't seen.
Who is the study for?
This trial is for Canadian adults with mild to moderate toenail fungus, specifically dermatophytes affecting the great toenail. Participants should have a target toenail thickness of 3mm or less and not be pregnant or breastfeeding. They must agree not to use other fungal treatments during the study and cannot have diabetes, certain nail conditions, metal implants in the foot/ankle area, allergies to microwave therapy, or be immunocompromised.Check my eligibility
What is being tested?
The study tests three different schedules of Swift Microwave treatment on toenail fungus: weekly for four weeks; every other week for four weeks; and every other week for twenty-four weeks. The effectiveness will be judged by adverse events related to treatment, clinical improvement of the treated nail, and elimination of the fungus at various intervals up to one year after starting treatment.See study design
What are the potential side effects?
Potential side effects from Swift Microwave treatments may include discomfort at the site of application, skin irritation around the treated nail, temporary increase in local temperature sensation during treatment sessions. Specific side effects will be monitored as part of this pilot study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a fungal nail infection in my big toenail.
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My big toenail is 20-75% affected by the condition.
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My toenail fungus is confirmed to be caused by a specific fungus.
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I have 4 or fewer toenails with signs of fungal infection.
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I agree not to take oral antifungal or treat nail fungus topically during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 9, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 9, month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients able to complete treatment regimen per protocol
Proportion of Patients per group with 'Temporary Increase in Clear Nail'
Secondary outcome measures
Number of patients able to complete Long-term treatment
Proportion of patients achieving End of Month 6 Efficacy
Proportion of patients per group with Effective Cure
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Group C-Biweekly x 24wksExperimental Treatment1 Intervention
Subjects will receive treatment on Day 0 and then once every two weeks in the first six months (12 treatments).
Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Group II: Group B-Biweekly x4wkExperimental Treatment1 Intervention
Subjects will receive treatment on Day 0 and then every two weeks in the first month followed by monthly treatment to Month 6 (7 treatments).
Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
Group III: Group A-Weekly x 4wkExperimental Treatment1 Intervention
Subjects will receive treatment on Day 0 and then weekly in the first month followed by monthly treatment to Month 6 (9 treatments).
Subjects who do not meet the 'temporary increase in clear nail' criteria at Month 6 and/or Month 9 will be offered once monthly treatment for 3 additional months.
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Who is running the clinical trial?
Emblation LimitedIndustry Sponsor
3 Previous Clinical Trials
202 Total Patients Enrolled
Mediprobe Research Inc.Lead Sponsor
Aditya Gupta, MD,PhDPrincipal InvestigatorMediprobe Research Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used metallic or ionic treatments on my toenail in the last 6 months and agree not to use any during the study.I am 18 years old or older.I can participate in all required study check-ups and tests.I have severe athlete's foot in a moccasin pattern.I have a fungal nail infection that affects the surface of my nail.I have a fungal nail infection with thick masses under the nail.I have a fungal nail infection in my big toenail.My toenail fungus extends less than 3mm from the base of my nail.My nail infection is caused by rare fungi or non-fungal organisms.I am at high risk for bacterial infections because of skin damage caused by a fungus.I have a health condition like psoriasis that affects my nails.Your toenails are 3mm thick or less.I have a fungal nail infection near the cuticle.I have been diagnosed with diabetes.I have had cellulitis more than once.I have a condition where my lymphatic system is not working properly.My nails are infected with a fungus called Candida.My big toenail is 20-75% affected by the condition.I have had toenail surgery that left my toe looking different.My toenail fungus is confirmed to be caused by a specific fungus.I have 4 or fewer toenails with signs of fungal infection.You have metal implants in your foot or ankle.I agree not to take oral antifungal or treat nail fungus topically during the study.I have a condition affecting the blood vessels outside my heart and brain.My treatment targets the white half-moon area at the base of my nail.People who have foot injuries from shoes that don't fit well, running, or aggressive nail care.I regularly receive foot or nail care from a professional.You have an implanted heart device like a defibrillator or pacemaker.My nails show lines, spots, streaks, yellowing, green debris, or notches but no fungal infection.You have an infection close to your fingernail that is less than 3mm away from the base of the nail.I do not have a foot infection that needs treatment during the study.I haven't used any nail fungus creams for 3 months or oral antifungals for 6 months.My immune system is weak due to a condition or treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Group B-Biweekly x4wk
- Group 2: Group C-Biweekly x 24wks
- Group 3: Group A-Weekly x 4wk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project actively searching for participants?
"According to the clinicaltrials.gov database, this trial has been inactive since it was last edited on December 29th 2022 and is no longer recruiting participants. However, there are presently 9 other studies in need of volunteers."
Answered by AI
What objectives are being pursued with this experiment?
"According to Emblation Limited, the trial's main measure of success is based on a 6-month interval and will be looking at the Proportion of Patients per group with 'Temporary Increase in Clear Nail'. Additionally, this study has delineated secondary outcomes including; Proportion of patients achieving End of Month 6 Efficacy, Mycological Cure (Microscopy negative/Culture Negative) and Effective Cure (<=10% affected area in target toenail with mycological cure)."
Answered by AI
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