Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Primary Performance (Efficacy) Endpoint
研究概览
简要总结
The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules.
详细描述
This is a post-market, prospective, single-arm, multicentre, non-randomized, observational study which will enrol up to 35 subjects in total (plus replacements) at up to 6 clinical investigation sites in Europe and potentially 1 site in the US.
Prospective patients must have a suitable soft tissue lung lesion and be candidates for an elective endobronchial navigation and microwave ablation procedure performed bronchoscopically. 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. Patients who meet the eligibility requirements will undergo a pre-procedural assessment, a bronchoscopy procedure that includes ablation treatment with MicroBlate™ Flex AB1, a post-procedural assessment and 6 follow-up visits at, 7 days (by phone call or in person), 31-45 days, 3 months, 6 months, 9 months and 12 months.
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
- •The participant may enter the study if ALL of the following apply:
- •The patient:
- •Has signed the informed consent form
- •Are ≥ 18 years old
- •Has lung lesion(s)/nodule(s) which are histologically confirmed or highly suspicious for cancer and is a candidate for bronchoscopic microwave ablation (as determined by a multi-disciplinary team (MDT) or tumour board).
- •Has a medically inoperable soft tissue lung lesion(s) ≤ 20 mm (suspected or confirmed malignancy), or patient has elected not to have surgery / alternative therapy.
- •Patient is a candidate for bronchoscopy under general anaesthesia.
- •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
- •The participant may not be enrolled in the study if ANY of the following apply:
- •For patients undergoing procedures employing robotic-assisted bronchoscopy:
- •1. a. Target nodule(s) are within 10mm of the trachea, right and left main bronchus, aorta, central pulmonary arteries, heart, oesophagus, spinal cord, phrenic & laryngeal nerves.
- •Note: Exclusion Criteria 1a is UK-specific.
- •For patients undergoing procedures without the use of robotic-assisted bronchoscopy (manual procedures):
- •b. Target nodule(s) are within the International Association for the Study of Lung Cancer (IASLC) "Central Zone" (including bronchial tree, major vessels, heart, oesophagus, spinal cord and phrenic and laryngeal nerves), or are <10 mm from the pleura.
- •Are assigned status 4 via ECOG (Eastern Cooperative Oncology Group) classification.
- •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.
- •Are scheduled for concurrent interventional procedure for the target soft tissue lesion.
- •Have a physical or psychological condition or other factor(s) that would impair study participation, or jeopardise the safety or welfare of the subject.
- •Have an expected survival less than 6 months.
- •Have patients with bleeding diathesis, uncorrectable coagulopathy or platelet count ≤ 100 x 10⁹ /L.
- •Have an implantable devices, 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 cannot be stopped or temporarily withheld.
- •Any patient with clinically significant interstitial lung disease in the zone of planned ablation.
- •Note: Exclusion Criteria 12 is NL-specific.
- •Patient has nodal disease confirmed through invasive or image-based staging. Note: if nodal disease is suspected or detected during the staging procedure conducted prior to use of the investigational device during the study procedure, the subject will be excluded.
- •Subject had a prior pneumonectomy.
研究组 & 干预措施
Microwave ablation
Patients with a single or multiple soft tissue lung lesions that is medically inoperable or for which the patient has declined surgical resection.
干预措施: Ablation (Device)
结局指标
主要结局
Primary Performance (Efficacy) Endpoint
时间窗: Up to day 30 patient visit.
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 and confirmed ablation as evidenced by assessment of CT. The criterion for meeting the Performance (efficacy) endpoint excludes study system malfunctions.
Primary Safety Endpoint
时间窗: Up to 30 days after the ablation procedure.
Identification of serious device-related adverse events related to the use of the AB1 system up to 30 days after the ablation procedure (number and nature of serious adverse events, both device- and procedure- related, will be identified) including, but not limited to: * Moderate bleeding (intervention required such as use of balloon tamponade or Surgicel) or severe bleeding (prolonged monitoring necessary or fatal bleeding) * Pneumothorax * Failure of extubation * ICU admission for respiratory failure within 30 days * Death within 30 days.
次要结局
- Secondary Safety Endpoint(Up to 12 months post ablation.)
- Secondary Effectiveness Outcomes - Rate of tumor recurrence(Up to 12 months)
- Secondary Effectiveness Outcomes - European Organization for Research and Treatment of Cancer Quality of life questionnaire - Cancer (EORTC QLQ-C)(Up to 12 months)
- Secondary Effectiveness Outcomes - EQ-5D-5L health-related quality of life questionnaire(Up to 12 months)
- Secondary Effectiveness Outcomes - Patient-reported pain rating on a visual analogue scale(Up to 45 days post-ablation)
- Secondary Effectiveness Outcomes - Assessment/visualization/quantification of the dimensions of the ablated tissue(Up to 12 months)
- Secondary Effectiveness Outcomes - Procedural Time(Up to 1 day post ablation procedure.)
- Secondary Effectiveness Outcomes - Assessment of ease of system use (clinician questionnaires)(Up to 1 day post ablation procedure.)