Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates - UK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Safety of the MicroBlate Flex AB1 system in lung tumour ablation
研究概览
简要总结
This study involves the use of a medical device, the Creo Medical MicroBlate Flex instrument, to heat and destroy lung tumour cells using microwave energy (this is also called ablation). In this study, the investigators are investigating whether the ablation instrument can be used effectively to treat lung tumours or tumours that have spread to the lungs. If successful, using this technology may mean future patients may not need to undergo surgical removal of these types of lung tumours.
The aim of this study is to evaluate the safety and performance of the MicroBlate Flex instrument in treating individuals with cancerous lung tumours that are due to be removed by surgery. All participants in the study will undergo the microwave ablation procedure, which is a separate and additional procedure to their surgical procedure.
The study, funded by Creo Medical, will be conducted at sites in the UK and Italy, and will involve up to 18 participants.
详细描述
Participation (approximately 2 months) in this study, will include a screening visit, a bronchoscopy procedure that includes the microwave ablation treatment, and the planned surgical removal of the lung tumour 7 to 21 days after the ablation.
There are 2 follow-up visits, one at 7 days after the ablation treatment, the second just before the planned surgical procedure. After surgery, patients will be monitored according to the hospital's routine clinical practice. Participation in the research study ends once the patient is discharged from hospital.
Participation in this study has the potential to provide the following benefits for other people who have the same medical condition:
- The option of choosing microwave ablation as an alternative treatment for lung tumours and avoiding a major surgical procedure.
- Shorter patient recovery times.
- Reduced incidence of complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who:
- •Have signed informed consent.
- •Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- •Are ≥ 18 years old.
- •Have lung lesion(s)/nodule(s) which are histopathological confirmed as cancer.
- •Have soft tissue lung lesion(s):
- •≤ 20 mm in the largest dimension of the pulmonary window
- •Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
- •> 10 mm of tumour-free lung parenchyma between target tumour and pleura or fissure.
- •Subject is willing and able to comply with the study protocol requirements.
- •Are assigned an ASA (American Society of Anaesthesiologists) score of ≤ 3 or the patient is deemed fit for general anaesthesia.
排除标准
- •Patients who:
- •Have target nodule(s) within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord, and phrenic & laryngeal nerves).
- •Are pregnant or breast feeding, as determined by standard site practices.
- •Have participated in an investigational drug or device research study within 30 days of enrolment that would interfere with this study.
- •Have a physical or psychological condition that would impair study participation or jeopardise the safety or welfare of the subject.
- •Have an expected survival less than 12 months.
- •Have an implantable device, including pacemakers or other electronic implants.
- •Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
- •Subject had a prior pneumonectomy.
- •Diagnosis of Small Cell Lung Cancer.
- •Subject had a therapeutic intervention (e.g., SBRT) within same lobe as the target lesion.
- •Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3 months of planned Study procedure.
研究组 & 干预措施
Microwave ablation
Patients with a malignant lung nodule who are candidates for surgical resection.
干预措施: Ablation (Device)
结局指标
主要结局
Safety of the MicroBlate Flex AB1 system in lung tumour ablation
时间窗: Up to 21 days after the ablation procedure
Identification of serious device-related adverse events associated with the delivery of microwave energy by the AB1 system from ablation (Day 0) up to the first surgical incision for the resection (Day 7-21)
Technical Success and Performance of the AB1 instrument
时间窗: Up to 28 days post ablation procedure
Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of the scheduled microwave energy to the target tissue (per pre-specified target) and confirmed ablation as evidenced by macroscopic assessment post-surgical resection of the ablated lesion
次要结局
- Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion(Up to 1 week post surgical resection procedure)
- Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT(Up to 1 week post ablation procedure)
- Procedural Time(Up to 1 week post ablation procedure)
- Assessment of ease of system use (Clinician Questionnaires)(Up to 1 week post ablation procedure)