Microwave Treatment (Swift System) for Warts

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tennessee Clinical Research Center, Nashville, TN
Warts
Microwave Treatment (Swift System) - Device
Eligibility
18 - 65
All Sexes
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Study Summary

This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 110 subjects that require treatment for up to 5 common or plantar warts. Subjects will be randomized to one of two treatment groups: Microwave Treatment (Swift® system) or Cryotherapy.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 3 months, 6 months and 12 months post final treatment

Month 12
Adverse events
Month 3
Clearance of all treated warts at three months post final treatment, each of which is defined as "lesion no longer visible" but assessed by the majority of three independent blinded assessors using photographs
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at three months post final treatment (up to 5 warts in total).
Efficacy of all warts classed as resolved by the blinded site investigator at three months post final treatment, by the number of warts treated
The resolution rate for individual warts based on the classification by the blinded site investigator at 3 months post-final treatment.
Month 12
Change from baseline for size of treated warts at three months, six months and at twelve months post final treatment
Patient reported pain score since last treatment at three, six and twelve months post final treatment
Month 12
Patient reported satisfaction with treatment at six and twelve months post final treatment
Month 12
Clearance of all treated warts, each of which is defined as "resolved" or "not resolved" based on the classification by the blinded site investigator assessing the treated warts at six months and twelve months post final treatment.
Reoccurrence of any treated wart at six and twelve months post final treatment, as classified by the blinded site investigator and separately by photos reviewed by the majority of the three independent blinded assessors.

Trial Safety

Trial Design

2 Treatment Groups

Cryotherapy Treatment
1 of 2
Microwave Treatment (Swift System)
1 of 2
Active Control
Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Microwave Treatment (Swift System) · No Placebo Group · N/A

Microwave Treatment (Swift System)
Device
Experimental Group · 1 Intervention: Microwave Treatment (Swift System) · Intervention Types: Device
Cryotherapy Treatment
Device
ActiveComparator Group · 1 Intervention: Cryotherapy · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months, 6 months and 12 months post final treatment
Closest Location: Tennessee Clinical Research Center · Nashville, TN
Photo of Nashville  1Photo of Nashville  2Photo of Nashville  3
2012First Recorded Clinical Trial
2 TrialsResearching Warts
76 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You agree to not take any NSAIDs or antihistamines within a 12-hour period prior to and after randomization.
You are willing to comply with all study procedures and are available for the duration of the study.
You are between 22 and 64 years old.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.