A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Medically Inoperable Primary Soft Tissue Lesions of the Lung: An Initial Experience
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 9
- 主要终点
- Number of Patients Whose Ablation Resulted in Technique Efficacy
研究概览
简要总结
Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach by an interventional pulmonologist or thoracic surgeon using CT imaging. Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging. Patients will be followed for one year following the ablation procedure for efficacy and safety.
详细描述
Patients with medically inoperable primary soft tissue lesion of the lung (lesions less than or equal to 2cm and located in the outer two-thirds of the lung and not closer than 1cm to the pleura) will have transbronchial microwave ablation performed using CT imaging. All ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon.
Prior to the ablation procedure, the treating physician will use endobronchial ultrasound to confirm staging.
Patients will be followed for one year following the ablation procedure for efficacy and safety with specific follow-up visits at 30 days, 6 months, and 12 months post-ablation. A user experience questionnaire is completed by the treating physician to better understand the ease of the procedure.
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
- •Signed informed consent.
- •Patients ≥ 18 years old.
- •Performance status 0-2 via ECOG (Eastern Cooperative Oncology Group) classification.
- •Willing to fulfill all follow-up visit requirements.
- •Medically inoperable primary soft tissue lesion of the lung or patient election not to have surgery. (Medically inoperable is defined per the following indicators: post op predictive FEV1 (forced expiratory volume in 1 second) < 40%; DLCO (diffusing capacity of the lung for carbon monoxide) < 40%; hypoxemia or hypercapnia diabetes with end-organ damage; or severe cerebral, cardiovascular, peripheral vascular disease, or chronic heart disease)
- •One soft tissue lesion ≤ 2 cm in the outer two thirds of the lung and not closer than 1 cm to the pleura.
- •(Outer two thirds of the lung is defined as peripheral beyond the segmental airway, past the segmental bronchi, such that proximal endobronchial soft tissue lesions are avoided; soft tissue lesions should not be contiguous with the pleura)
- •Radiographic resolution of pneumonia
排除标准
- •Scheduled concurrent procedure for the target soft tissue lesion other than those that are lung related.
- •Pregnant or breastfeeding.
- •Physical or psychological condition that would impair study participation.
- •Patients with uncorrectable coagulography at time of screening.
- •Patient with implantable devices, including pacemakers or other electronic implants.
- •Prior pneumonectomy or bronchiectasis.
- •Severe neuromuscular disease.
- •Platelet count ≤ 50,000/mm
- •ASA (American Society of Anesthesiologists) score of ≥
- •Inability to tolerate anesthesia.
- •Expected survival less than 6 months.
- •Clinically significant hypertension.
- •Chronic ventilator support, which uses bi-level positive airway pressure (PAP).
- •Endobronchial soft tissue lesions proximal to the segmental airways
结局指标
主要结局
Number of Patients Whose Ablation Resulted in Technique Efficacy
时间窗: 30 days post-ablation
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT imaging, 30 days (+/- 7 days) after the first ablation procedure.
User Experience Survey (Part II)
时间窗: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the time it took to place the probe in a position that was ready for ablation.
User Experience Survey (Part I)
时间窗: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. Questions were all YES/NO.
User Experience Survey (Part III)
时间窗: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many cone-beam CT (CBCT) scans were taken to place the probe such that it was ready for ablation.
Number of Patients Whose Ablation Resulted in Technical Success
时间窗: Immediately post-ablation (day 0)
Ablation of the target lesion according to the protocol and covered completely, with an adequate margin, as defined by the performing physician (that is, the ablation zone completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CBCT imaging, immediately following the procedure.
User Experience Survey (Part V)
时间窗: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked how many times the probe had to be repositioned to complete the ablation procedure.
User Experience Survey (Part IV)
时间窗: Immediately post-ablation
A Sponsor-created survey completed by the treating physician immediately post-ablation. This question asked the distance of the tip of the probe to the center of the soft-tissue lesion (in mm) just before the ablation procedure was initiated.
次要结局
- Number of Patients Who Experienced Target Lesion Recurrence(measured at 6 months and 1 year post-ablation)
- Number of Patients Who Were Readmitted to the Hospital(Within 30 days post-ablation)