A Prospective, Non-Randomized, Multicenter Pivotal Study of Nano-Pulse Stimulation™ (NPS™) Treatment of Cutaneous Non-Genital Warts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 10
- 主要终点
- Percentage of Verrucae Cleared
研究概览
简要总结
This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.
详细描述
The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Percentage of Verrucae Cleared
时间窗: 60-days post-last CellFX treatment
Percentage of Verrucae with Clearance (91-100% reduction)
次要结局
- Subject Satisfaction(60-days post-last CellFX treatment)