Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue in Surgical Candidates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The overall purpose of this study is to characterise the clinical safety and performance of the Creo Medical MicroBlate™ Flex AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation prior to surgery.
详细描述
This is a post-market, prospective, single-arm, multicentre, open-label, non-randomised study which will enrol up to 30 subjects in total (plus replacements if required due to drop out).
Prospective patients must have a histopathological-confirmed malignant lung lesion and be candidates for surgical resection. After being informed about the study and potential risks, all patients giving their written informed consent will undergo a screening visit to determine eligibility for study entry.
The study consists of two (2) stages (Stage A and Stage B). Stage A consists of the ablation and surgical resection being performed concurrently on Day 0 within a single procedure. Stage B consists of the ablation and the surgical resection being performed in separate procedures. The surgical resection will occur between Day 7 and Day 21, post-ablation, inclusive of those days. The aim is to follow local guidelines for treatment of lung cancer.
Patients undergoing Stage A will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).
Patients undergoing Stage B will have evaluations at follow-up visits conducted at 7 (+/-3) days (via phone call) post ablation and prior to the surgical resection procedure. Stage B patients will be released from the study at point of standard of care discharge from hospital post-surgery and will not be followed as part of the study (patients will receive SoC follow-up and care post release from study).
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):
- •≤ 30 mm in the largest dimension of the pulmonary window for Stage A.
- •≤ 20 mm in the largest dimension of the pulmonary window for Stage B.
- •Are candidates for surgical resection as determined by a multi-disciplinary team (MDT) or tumour board.
- •Greater than 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 bleeding diathesis, uncorrectable coagulopathy, or platelet count ≤ 100 x 10^9/L.
- •Have an implantable device, including pacemakers or other electronic implants.
- •Have known pulmonary hypertension (PASP [pulmonary artery systolic pressure] >50mmHg).
- •Who are currently prescribed anticoagulants, clopidogrel or other platelet aggregation inhibitors which can´t be stopped or temporarily withheld.
- •Subject had a prior pneumonectomy.
- •Diagnosis of Small Cell Lung Cancer.
- •Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
- •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.
结局指标
主要结局
Primary Safety Endpoint
时间窗: Day 7-21, post ablation procedure up to initiation of surgical resection procedure.
Stage B - Ablate (Day 0) \& Resect (Resection Day 7-21) Identification of serious device-related adverse events related to the use of the AB1 system from day 0 up to initiation of surgical resection procedure (number and nature of serious adverse events, both device and procedure related, will be identified).
Primary Performance (Efficacy) Endpoint
时间窗: Up to 1 week post ablation procedure.
Initial technical success, defined as successful bronchoscopic access by the AB1 instrument of the target tissue, delivery of 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.
Primary Safety Endpoint
时间窗: Day 0, day of ablation procedure up to initiation of surgical resection procedure.
Stage A - Ablate (Day 0) \& Resect (Day 0) Identification of serious device-related intra-procedural adverse events related to the use of the AB1 system on Day 0 prior to surgical resection defined by the initial skin incision (number and nature of serious adverse events, both device and procedure related, will be identified).
次要结局
- Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablated tissue including assessment of margin relative to lesion(Up to 1 week post ablation procedure.)
- Secondary Performance (Efficacy) Endpoints - Assessment/visualization/quantification of the dimensions of the ablation observed within the post-ablation CT(Up to 1 week post ablation procedure.)
- Secondary Performance (Efficacy) Endpoints - Procedural Time(Up to 1 week post ablation procedure.)
- Secondary Performance (Efficacy) Endpoints - Assessment of ease of system use (clinician questionnaires)(Up to 1 week post ablation procedure.)