癌研連線CancerLink
招募中 NCT07487064

Galvanize Aliya® EX脉冲电场（PEF）治疗及切除研究

肺癌不适用

一项前瞻性、单臂、非随机、单中心、开放标签的治疗及切除研究，随访患者至手术切除。本研究旨在评估Aliya EX系统利用脉冲电场（PEF）能量传递消融肺部病灶的安全性与可行性。

适应症：Lung Cancer

入组条件

纳入标准

  • 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.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。