癌研連線CancerLink
已終止 NCT05299606

POWER 研究（前瞻性經支氣管微波消融 + 機械人輔助支氣管鏡）

肺癌不適用

這是一項前瞻性、多中心、單臂研究，使用 NEUWAVE FLEX 微波消融系統及配件對周邊肺部寡轉移腫瘤進行經支氣管微波消融，由 Auris MONARCH 平台引導進行可視化及進入，同時使用錐形束 CT（電腦斷層掃描）確認探針尖端位置及最終消融區域。

適應症：Lung Neoplasms

收案條件

納入條件

  • Signed informed consent.
  • Subjects greater or equal to 22 years old.
  • Performance status 0-2 (Eastern Cooperative Oncology Group classification (ECOG).
  • Willing to fulfill all follow-up visit requirements.
  • Subjects with at least one oligometastatic lung tumor where the primary tumor is controlled (in the opinion of the investigator or treating oncologist).
  • Oligometastatic lung tumor(s) planned to be ablated in the outer two-thirds of the lung and not closer than 1cm to the pleura.

排除條件

  • Pregnant or breastfeeding.
  • Subjects with thoracic implantable devices, including pacemakers or other electronic implants.
  • Chronic, continuous ventilator support, which uses bi-level positive airway pressure (PAP) to improve lung function for severe conditions. (However, intermittent PAP, for non-pulmonary conditions, such as sleep apnea, is permitted).
  • Prior pneumonectomy.
  • Severe bronchiectasis (with FEV1 \<30%) or disease deemed to be too severe in the opinion of the investigator.
  • Platelet count ≤ 50,000/mm3.
  • Subjects with uncorrectable coagulopathy at time of screening.
  • Subjects medically unable to stop anti-platelet agents (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days prior to the procedure through 48-72 hours after the procedure.
  • Subjects medically unable to stop warfarin at least 3-5 days prior to the ablation procedure, or until INR \< 1.5, through 48-72 hours after the procedure. On the day of the procedure, subjects with an INR \> 1.5 cannot have the procedure completed that day but may be rescheduled or postponed.
  • Subjects medically unable to stop anticoagulants (e.g., rivaroxaban, apixaban, dabigatran, endoxaban) at least 3 days prior to the ablation procedure through 48-72 hours after the procedure.
  • Expected survival less than 6 months in the opinion of the investigator and/or treating oncologist.
  • Subjects with known or suspected brain metastases.
  • Subject has had any radiation (i.e., SBRT or EBRT) to the intended ablation zone.
  • Endobronchial tumors proximal to and including the segmental airways.
  • Lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned study ablation procedure or those who plan to receive a lung ablation, surgical resection, or radiation therapy on the ablated lung side before completing the primary endpoint assessment (30 days post-ablation).
  • Systemic therapy (e.g., chemotherapy, targeted drug therapy, or immunotherapy) within 14 days prior to the planned study ablation procedure or those who plan to receive systemic therapy before completing the primary endpoint assessment (30 days post-ablation).

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。