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Microwave Treatment of Common and Plantar Warts

Warts Clinical Trial

Official title:
Pivotal Study to Assess the Clinical Efficacy and Safety of Microwave Treatment in Warts

Clinical Trial Summary

This is a multi-center, open, randomized, parallel-group, controlled, blind-assessed trial of approximately 124 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.

Clinical Trial Description

The primary objective of this study is to collect evidence of the effectiveness of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy. The secondary objectives of this study are to collect evidence of the safety, effectiveness and patient experiences of the Swift device for the treatment of common and plantar warts and compare with Cryotherapy. Eligible subjects who provide written informed consent will be randomized to either Microwave Treatment or Cryotherapy. Each eligible subject will receive treatment at the baseline visit (Visit 2) and again 4-weeks later. Subjects will receive a minimum of 2 treatments or, if further treatment is required, up to a maximum of 4 treatments; each treatment is given in 4-week intervals. Follow-up is 12-weeks after the last treatment has been administered where the warts will be assessed for resolution. Further follow-up visits occur 6-months and 12-months after the last treatment where the warts will be assessed for resolution or reoccurrence (if resolved at the 12-week visit). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05371834
Study type Interventional
Source Blackwell Device Consulting
Contact
Status Active, not recruiting
Phase N/A
Start date July 6, 2022
Completion date March 2025
View Details
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