A Multicenter Study of the NEUWAVE Flex Microwave Ablation System in the Ablation of Secondary Soft Tissue Lesions of the Lung
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 9
- 主要终点
- Device User Experience Survey
研究概览
简要总结
Patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung will have transbronchial microwave ablation performed using cone beam CT for probe guidance and confirmation.
详细描述
Adult patients with medically inoperable and operable secondary soft tissue lesion(s) of the lung less than 2cm will undergo transbronchial microwave ablation performed by an interventional pulmonologist or thoracic surgeon using cone beam CT imaging for probe guidance and confirmation on ablation outcome. All treated patients will be followed for one year following the ablation procedure for efficacy and safety.
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 greater or equal to 18 years of age
- •Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG])
- •Willing to fulfill all follow-up visit requirements
- •Medically inoperable and operable secondary soft tissue lesion(s) of the lung
- •A maximum of two ipsilateral soft tissue lesions less than or equal to 2cm in the outer two-thirds of the lung and not closer than 1cm to the pleura. Lesion size must be measured with at least 2-dimensional imaging.
排除标准
- •Scheduled concurrent procedure for the target soft tissue lesion(s) other than those that are lung-related
- •Pregnant or breastfeeding
- •Physical or psychological condition that would impair study participation
- •Patients with uncorrectable coagulopathy at the time of screening
- •Patient with implantable devices, including pacemakers or other electronic implants
- •Prior pneumonectomy or bronchiectasis
- •Severe neuromuscular disease
- •Patient count less than or equal to 50,000/mm cubed
- •ASA (American Society of Anesthesiologists) score of greater than or equal to 4
- •Inability to tolerate anesthesia
- •Expected survival less than 6 months
- •Clinically significant hypertension
- •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)
- •Endobronchial soft tissue lesions proximal to the segmental airways
- •Imaging findings of active pulmonary infection
- •The patient was judged unsuitable for study participation by the Investigator for any other reason.
结局指标
主要结局
Device User Experience Survey
时间窗: Day of ablation (day 0)
The Device User Experience Survey is an unvalidated, Sponsor-generated questionnaire aimed to increase the Sponsor's understanding of the usability of the NEUWAVE microwave ablation system. The questionnaire asks approximately 30 questions (includes yes/no responses, rating scales, and fill-in-the-blank sections) and is to be completed by the treating physician at the completion of each ablation. A summary of all treating physician responses will be generated at the completion of the study to summarize the overall user experience with the device.
Technique Efficacy (lesion completely ablated)
时间窗: 30 days post-ablation
Technique Efficacy is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, at Visit 3 (i.e. 30 days post-ablation).
Technical Success (lesion completely ablated)
时间窗: Day of ablation (day 0)
Technical Success is determined by the treating physician and is defined as the ablation zone completely overlapping or encompassing the target lesion plus an ablative margin, as assessed by cone beam CT imaging, immediately following the ablation procedure.
次要结局
- Primary Efficacy Rate(Day of ablation (day 0))
- Hospital Readmission Rate(30 days post-ablation)
- Length of Hospital Stay(Day of ablation (day 0))
- Adverse Events(1 year post-ablation)
- Secondary Efficacy Rate(1 year post-ablation)
- Target Lesion Recurrence(1 year post-ablation)