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Procedure
Microwave Treatment vs Freezing for Warts
N/A
Waitlist Available
Led By Dr Bhatia
Research Sponsored by Blackwell Device Consulting
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 22-64 years inclusive;
Subject's common warts must measure between 3mm-10mm or for plantar warts, measure between 3mm-20mm, inclusive;
Must not have
Subject with known immunosuppression disorders through illness or medication (for example - corticosteroids, biologic agents, methotrexate, ciclosporin)
Dependent lymphedema
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months and 12 months post final treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two treatments for common and plantar warts: Microwave Treatment and Cryotherapy. Microwave Treatment uses heat to destroy the wart, while Cryotherapy uses freezing. The study aims to see which method is more effective and safe for patients.
Who is the study for?
This trial is for adults aged 22-64 with at least one significant common wart (3mm-10mm) or plantar wart (3mm-20mm), not mixed. Participants must stop current wart treatments 28 days before, avoid NSAIDs and antihistamines around treatment times, and commit to the study duration without using other wart products.
What is being tested?
The trial compares two treatments for warts: Microwave Treatment using the Swift system versus Cryotherapy. It's a randomized controlled study where participants are assigned to either method without knowing which group they're in but outcomes are assessed blindly.
What are the potential side effects?
Potential side effects of microwave therapy may include discomfort, skin irritation, or swelling at the treatment site. Cryotherapy can cause pain during application, redness, blistering, and possible scarring on the treated area.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 64 years old.
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My warts are within the size range required for the study.
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I have at least one significant wart on my hand, knee, or elbow, or two on my feet.
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I am between 18 and 64 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition or take medication that weakens my immune system.
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I have swelling due to fluid buildup that requires assistance.
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I have had deep vein thrombosis in the past.
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I have nerve damage in my hands or feet.
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I have skin irritation or inflammation in the areas needing treatment.
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I have had cellulitis at least twice.
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I've had procedures on my legs that are considered too risky for this trial.
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I have diabetes.
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I have been diagnosed with congestive heart failure.
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I do not have any unstable heart conditions, active cancers, or severe joint inflammation.
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I have had surgery to remove lymph nodes in my armpit or groin.
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I have a blood circulation condition affecting my hands or feet.
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I am currently on prescribed blood thinners.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months, 6 months and 12 months post final treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months and 12 months post final treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Patient reported pain score since last treatment at three, six and twelve months post final treatment
Patient reported satisfaction with treatment at six and twelve months post final treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Microwave Treatment (Swift System)Experimental Treatment1 Intervention
5-10 Watts of microwave energy applied locally on each wart for a 2-3 second burst with 3-5 repetitions per lesion.
Group II: Cryotherapy TreatmentActive Control1 Intervention
For each wart, two cycles of cryotherapy treatment is administered.
Find a Location
Who is running the clinical trial?
Emblation LimitedIndustry Sponsor
3 Previous Clinical Trials
117 Total Patients Enrolled
Blackwell Device ConsultingLead Sponsor
1 Previous Clinical Trials
60 Total Patients Enrolled
Dr BhatiaPrincipal InvestigatorOak Dermatology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have warts with hair growth, birthmarks, dark moles, or unusual skin conditions.I have a condition or take medication that weakens my immune system.You have an implanted device like a defibrillator or pacemaker.I agree to stop my current wart treatment 28 days before the study starts.I have had warts for more than 5 years.I have swelling due to fluid buildup that requires assistance.I am between 22 and 64 years old.My warts are within the size range required for the study.I can participate in all required study check-ups and tests.I have at least one significant wart on my hand, knee, or elbow, or two on my feet.I have warts on sensitive areas like my face, neck, or genitals.I have had deep vein thrombosis in the past.I am willing and able to follow all study rules and attend all appointments.I am between 18 and 64 years old.I have nerve damage in my hands or feet.I haven't had an infection in the treatment area in the last 3 months.I have mosaic warts that need treatment.I have skin irritation or inflammation in the areas needing treatment.I have had cellulitis at least twice.I've had procedures on my legs that are considered too risky for this trial.You have used any metal-based treatments on your skin in the past year.You have an autoimmune disease.I have diabetes.I have been diagnosed with congestive heart failure.You have metal implants in your foot or ankle where the treatment would be applied.I agree not to take NSAIDs or antihistamines around my treatment times.I do not have any unstable heart conditions, active cancers, or severe joint inflammation.I have had surgery to remove lymph nodes in my armpit or groin.My common warts are between 3mm-10mm, or my plantar warts are between 3mm-20mm.You are allergic or intolerant to microwave therapy and cryotherapy.I am willing and able to follow all study rules and attend all appointments.I have a blood circulation condition affecting my hands or feet.I am currently on prescribed blood thinners.I agree to stop my current wart treatment 28 days before the study starts.I have at least one significant wart on my hand, knee, or elbow, or a plantar wart.
Research Study Groups:
This trial has the following groups:- Group 1: Microwave Treatment (Swift System)
- Group 2: Cryotherapy Treatment
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.