A Targeted Ablation and Resection Study With Galvanize Aliya® EX Pulsed Electric Field (PEF) Technology
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Device and Procedure related serious adverse event rate
研究概览
简要总结
A prospective, single-arm, non-randomized, single-center, open-label, treat and resect study following patients through surgical resection. The study is designed to evaluate the safety and feasibility of the Aliya EX System for the ablation of pulmonary lesions using pulsed electric field (PEF) energy delivery. The study is intended for adult patients with suspected or confirmed pulmonary malignant lesion(s) ≥1.5 cm to ≤4 cm whom are surgical candidates and have not received treatment for the index tumor in the last two years.
详细描述
This study is to evaluate the safety and technical success of delivering Aliya® pulsed electric fields (Aliya PEF) for ablation of pulmonary lesions in patients with suspected or confirmed malignancy, prior to planned surgical resection.
Treatment may be delivered via either an endoluminal (bronchoscopic) or percutaneous approach at the discretion of the clinical investigator utilizing two available device configurations:
Bronchoscopic approach: Aliya® EX Generator, the INUMI Flex Needle and the Aliya® Electrode.
Percutaneous approach: Aliya® EX Generator, the Aliya® Needle and the Aliya® Electrode.
The study will enroll and treat up to 25 adult patients with suspected or confirmed pulmonary malignant lesion(s) in patients whom are surgical candidates at 1 clinical site.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of at least one lesion in the lung measuring ≥ 1.5 cm and ≤ 4 cm diameter by computed tomography (CT) size estimate deemed suitable for PEF ablation per institutional guidelines.
- •High probability of malignancy as determined by the investigator.
- •Patient has been deemed a candidate for definitive lung tissue resection per institutional SOC.
- •Patient is, in the opinion of the Principal Investigator (PI), able to adhere to and undergo the PEF and surgical procedures.
- •Patient is able to tolerate general anesthesia.
- •Patient is 18 years of age or older.
- •Patient has provided informed consent.
排除标准
- •Patient requires neoadjuvant therapy for the disease for which surgical resection is intended.
- •Patient is receiving concurrent cancer treatment (e.g., external beam radiation therapy, brachytherapy, chemotherapy, targeted therapy, immunotherapy, other focal therapy).
- •Patient has received effective treatment for the target lesion in the last two years prior to the date of consent.
- •Patient has undergone prior pneumonectomy.
- •Patient has a serious medical condition that, in the Principal Investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to PEF ablation (e.g., major organ dysfunction, active autoimmune disease, immune compromised or receiving immune modulating medication that has resulted in substantial clinical change).
- •Patient is receiving oral corticosteroid therapy (>10mg/day or equivalent) within 30 days of the PEF procedure.
- •Patient is currently enrolled in another interventional clinical trial.
- •Patient has a physical or psychological condition that would impair study participation or jeopardize the safety or welfare of the patient.
- •Women of childbearing potential who are pregnant, nursing, or planning to get pregnant during their participation in the study.
结局指标
主要结局
Device and Procedure related serious adverse event rate
时间窗: From the PEF procedure through surgical resection (approximately 30 days later)
Rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Technical success
时间窗: Intra-procedural
The frequency with which the clinician can access the target lesion and deliver PEF energy
次要结局
未报告次要终点