A Multicenter, Prospective, Randomized, Comparison IDE Study Between the Pulse Biosciences CellFX System and Cryosurgery for the Treatment of Cutaneous Non-Genital Common Warts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 18
- 主要终点
- Percentage of Warts Resolved
研究概览
简要总结
This prospective, multicenter, single-blinded, randomized comparison study is designed to compare the safety and effectiveness of the CellFX System to Cryosurgery for the clearance of cutaneous non-genital common warts on all areas of the body excluding the scalp, nose, within the orbital region of the face, plantar or periungual area in healthy adult subjects.
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. Macrophotography of all study warts will be captured along with a blinded site Investigator to characterize wart healing, wart clearance and wart reduction. All subjects will be followed at 7, 30, 60, and 90-days following the last CellFX or Cryosurgical Procedure. All wart lesions are eligible for up to a total of 3 treatments 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Each subject will be evaluated by the blinded site investigator conducting assessment of outcomes at 7, 30, 60, and 90-days following CellFX and Cryosurgical treatments.
入排标准
- 年龄范围
- 22 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
- •Subject has a Fitzpatrick Skin Type I, II, III or IV.
- •Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Subject must comply with study procedures including all follow-up visits.
- •Subject is willing to have warts treated in a single treatment session and understands that their warts may undergo multiple treatment sessions at subsequent visits.
- •Subject must have a minimum of 2 warts and up to 8 warts to be treated.
- •Subject with a clinical diagnosis of common warts located on hands and fingers or other body areas that are not located on the scalp, nose, within the orbital region of the face, plantar, genital or periungual area.
- •For study purposes, the warts must be no greater than 3 mm in height and must not exceed 10mm x 10mm at their largest dimension.
- •Each wart must appear alone and discrete and not appear in clusters.
- •Each wart must have been present for at least 4 weeks.
- •Subject consents to have photographs taken of the warts.
- •Subject agrees to refrain from using all other wart removal products or treatments (e.g.
- •topical medication including over-the-counter medications) during the study period.
排除标准
- •Subject with more than 8 visible warts in total anywhere on the body.
- •Subject has flat, periungual, subungual, genital, anal, mosaic, plantar or filiform warts.
- •Subject has an implantable electronic medical device.(i.e., pacemaker, implantable cardioverter defibrillator)
- •Subject has an active infection or history of infection in designated test area within 90 days prior to first treatment.
- •Subject is taking antihistamines, including those used for gastric symptoms.
- •Subject is prone to Koebnerization or has any of the following conditions (e.g., psoriasis, vitiligo, lichen planus, or an autoimmune disorder of the skin)
- •Subject is not willing or able to sign the Informed Consent.
- •Subject is known to be immune compromised.
- •Subject has allergies 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.
- •Have any condition or situation which, in the Investigator's opinion, puts the subject at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study.
- •Use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study.
- •Subject was previously treated with CellFX for warts.
结局指标
主要结局
Percentage of Warts Resolved
时间窗: 30 days following the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The primary effectiveness endpoint is the percentage of warts resolved or cleared as assessed "live" by the blinded site investigator at 30 days after the last treatment with CellFX or Cryosurgical Procedure.
Percentage of Warts Treated With Skin Textural Changes
时间窗: 30 days from the last CellFX or Cryosurgical Procedure up to a maximum of 3 months
The safety endpoint is the percentage of warts with skin textural changes where the wart was originally treated and showed textual changes of the surrounding skin where the wart was treated and included; scabbing, swelling, crusting, blister, or ulceration when assessed by the blinded site investigator.
Presence of Pigmentary and Scarring Skin Changes
时间窗: 90 days from the last CellFX or Cryosurgical Procedure up to a maximum of 6 months
The skin change safety event is defined as the presence of hyperpigmentation, hypopigmentation, or scarring as assessed by the blinded site investigator.
次要结局
未报告次要终点