NCT05299606终止不适用
A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 19
- 主要终点
- Number of Patients Whose Ablation Resulted in Technique Efficacy
研究概览
简要总结
This is a prospective, multicenter, single-arm study on transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone. The primary endpoint is Technique Efficacy, assessed 30-days post-ablation via CT imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/mm
- •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).
研究组 & 干预措施
Transbronchial Microwave Ablation
Experimental
Transbronchial microwave ablation will be performed using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone.
干预措施: Transbronchial Microwave Ablation (Device)
结局指标
主要结局
Number of Patients Whose Ablation Resulted in Technique Efficacy
时间窗: 30 days post-ablation
Technique Efficacy is defined as ablation of the target tumor(s) with the ablation zone completely overlapping or encompassing the entire target tumor(s) as assessed using CT imaging 30 days (- 7 to +14 days) after the ablation procedure.
次要结局
- Number of Patients Whose Ablation Resulted in Technical Success(Immediately post-ablation (Day 0))
- Number of Patients Who Experienced Local Tumor Progression(Assessed at 3 months, 6 months and 1 year post-ablation)
- Number of Patients Who Experienced Disease Progression(Assessed at 3 months, 6 months and 1 year post-ablation)
- Number of Patients Who Required Repeat Ablation of Target Lesion(Assessed at 3 months, 6 months and 1 year post-ablation)
研究者
研究点 (19)
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