Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04554394
Eligibility Criteria:
Inclusion Criteria:
* Subjects must be at least 21 and not older than 80 years of age
* Subjects must be able to read and speak English or Spanish
* Subjects must sign a written informed consent to participate in the study, prior to any study related procedures
* Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm
* Subject is willing to undergo all study-mandated procedures
* Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion Criteria:
* Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.)
* Subject has cochlear implants
* Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment
* Subject has a history of and/or current tinnitus
* Subject is known to be immune-compromised
* Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.)
* Subject has Type 1 Diabetes and is insulin dependent
* Subject has a known allergy to Lidocaine or Lidocaine-like products
* Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
* Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04554394
Study Brief:
Protocol Section:
NCT04554394