A Clinical Investigation in lUng canceR of the Endowave FlexAblate™ Microwave tRansbronchial Ablation System.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Technical Efficacy
研究概览
简要总结
The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system.
Participants in this clinical trial will be patients aged over 18 years who have been previously diagnosed with cancer in the lung (primary or secondary malignant tumours) and deemed unsuitable for surgery or are declining surgery or, patients suitable for microwave ablation procedure based on clinical assessment.
Those who meet all of the eligibility criteria at a screening assessment (a review of eligibility to participate in the study includes review of information on the cancerous nodule, recording your medical history, current medications, a blood test, and quality of life assessments) will undergo the ablation treatment with FlexAblate™ Microwave Ablation System. Follow-up assessments will be at week 1 and months 1, 3, 6 and 12 will includes CT Scans (CT or "CAT" scan is a computed tomography scan), blood tests, assessment of overall health and quality of life assessments.
详细描述
This is a prospective, single-arm, non-randomised clinical investigation. Up to 43 subjects will be enrolled from up to 5 sites. The clinical investigation is designed to evaluate the performance and safety of the Endowave FlexAblate™ Microwave Ablation System device in subjects undergoing lung ablation procedures. Microwave Ablation System device in subjects undergoing lung ablation procedures.
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
- •Adult ≥ 18 years of age who has provided signed informed consent.
- •Subject is able and willing to comply with the planned clinical investigation follow-up schedule
- •Pathological confirmed malignant nodule in the lung either primary or metastatic disease.
- •Target nodule is ≤ 20mm in maximum diameter.
- •There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure.
- •Subject is a candidate for an elective lung ablation procedure as determined by institutional multi-disciplinary board or equivalent.
- •Subject or the lesion is not suitable for surgery or patient refuses surgery.
排除标准
- •Target nodule is abutting main or lobar stem bronchus, main pulmonary vasculature (vessel 5mm), heart, oesophagus and/or trachea.
- •Subjects who are extremely breathless or on home oxygen therapy.
- •Female subjects who are pregnant or nursing.
- •Subjects with uncorrectable coagulopathy or thrombocytopenia at time of screening.
- •Subjects with prior pneumonectomy.
- •Subjects who have had any radiation (i.e., SBRT or EBRT) to the intended ablation zone or lung ablation, surgical resection therapy, radiotherapy, or any other treating procedure within 30 days prior to the planned 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).
- •Subjects who have implantable electronic devices, including pacemakers or other electronic implants.
- •Known pulmonary hypertension (Pulmonary artery systolic pressure, PASP >50mmHg).
- •Active active pulmonary infection at time of screening or the procedure.
- •Subjects medically unable to stop anticoagulant or anti-platelet therapy for relevant time period prior to and following the ablation procedure.
- •Participation in an investigational drug or device clinical investigation within 30 days of enrolment that would interfere with this clinical investigation.
- •The investigator determines that participation in this clinical investigation may jeopardise the safety or welfare of the subject.
研究组 & 干预措施
Transbronchoscopic Microwave Ablation
The FlexAblate™ Microwave Ablation System is deployed and used to conduct bronchoscopic ablations in the lung.
干预措施: Microwave Ablation (Device)
结局指标
主要结局
Technical Efficacy
时间窗: 1 month
Technical Efficacy defined as ablation of the target tumour with the ablation zone completely overlapping or encompassing the entire target tumour assessed using conventional CT imaging.
次要结局
- Quality of Life Assessment - Bronchoscopic Ablation Patient Pain and Satisfaction Survey(1 month)
- Quality of Life Assessment - EQ-5D-5L health-related quality of life questionnaire(12 months)
- Procedure Technical Success(Day of procedure)
- Ablation Technical Success(At Discharge - Day 1)
- Safety Assessment - number of device or procedure related Serious Adverse Events(Through to 1 month follow-up)
- Safety Assessment - number of device or procedure related Adverse Events (AE)(Through to 3 months)
- Quality of Life Assessment - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C30)(12 months)