A Multicenter, Prospective, Treat and Resect Feasibility Study of the CellFX System for the Treatment of Low-Risk Basal Cell Carcinoma (BCC) Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Number of Participants With Treatment Related Serious Adverse Events
研究概览
简要总结
This prospective, multicenter, study is designed to evaluate the safety and effectiveness of the CellFX System in adults subjects with low-risk basal cell carcinoma (superficial and nodular) for complete histological clearance of the target lesion followed by surgical tumor excision 60 days post-treatment.
详细描述
The study will enroll healthy adult subjects with confirmed low-risk (superficial and nodular) BCC lesion(s) by biopsy, excluding BCCs located on the face, neck, scalp, axilla, hands, feet, and genitals not exceeding 1.5 cm. Macrophotography of all study BCCs will be captured and clinically assessed by the site investigator for characterization of healing and scar appearance prior to and post-surgical excision. All subjects will be followed at 3, 7, 14, 30 and 60-days post-CellFX procedure and at 14, 30 and 60-days post-excision. Adverse events will be documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 22 and no older than 85 years of age.
- •Subject has 1-2 primary, non-recurrent, superficial, or nodular visible basal cell carcinoma lesion up to 1.5 cm in size with well-defined borders that has been verified by biopsy.
- •Lesion(s) is appropriate for full linear excision with 5 mm margins.
- •Subject is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •Subject gives voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- •Subject is willing to have BCC lesion(s) treated in a single treatment session and must comply with all study procedures including follow-up visits.
- •Subject consents to have photographs taken of the BCC lesion(s).
- •Subject agrees to refrain from using all other lesion removal products or treatments (topical medication including over-the-counter medications or treatments from PI or another physician) during the study period.
- •Subject agrees to refrain from prolonged sun exposure of the treatment area during the study period.
排除标准
- •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 four weeks prior to treatment.
- •Subject is not willing or able to sign the Informed Consent.
- •Subject is known to be immune compromised/has a history of immunosuppression (e.g., organ transplant, long-term use of psoralen) or genetic disease (e.g., nevoid basal cell carcinoma syndrome [Gorlin syndrome], xeroderma pigmentosum).
- •The basal cell carcinoma lesion intended for treatment with the CellFX System is on the face, neck, scalp, axilla, hands, feet, or genitals.
- •The basal cell carcinoma intended for treatment with the CellFX System is a high-risk BCC subtype including perineurial, infiltrative, sclerosing, morpheaform, desmoplastic, micronodular, basosquamous or exhibiting aggressive growth patterns.
- •Subject is known to be a keloid producer.
- •Subject has allergies to Lidocaine or Lidocaine-like products.
- •Subject has a history of radiation to the area intended for treatment.
- •Subject has current or prior metastatic BCC.
- •Subject is currently being treated or has been previously treated with Sonidegib or Vismodegib.
- •Subject has recurrent BCC lesions.
- •Subject has a systemic infection.
- •Subject has a history of epilepsy.
- •Subject has a history of cardiac arrhythmia, myocardial infarction or structural heart disease.
- •Subject is employed by the sponsor, clinic site, or entity associated with the conduct of the study.
- •Subject has 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.
- •Subject has a history of use of any other investigational drug, therapy, or device within the past 30 days of enrollment or concurrent participation in another research study, with the exception of participation in a COVID vaccination related clinical trial.
结局指标
主要结局
Number of Participants With Treatment Related Serious Adverse Events
时间窗: 60-days post-CellFX procedure
No serious adverse events related to CellFX Treatment or Procedure
Number of Lesions With BCC Histological Clearance
时间窗: 60-days post-CellFX procedure
The primary effectiveness endpoint is the total number of lesions with complete histological clearance of the BCC lesion during histological review of microscopic analysis using H \& E slides. Counts and proportions will be assessed.
次要结局
未报告次要终点