NL-OMON56949尚未招募不适用
Assessment of the Safety and Performance of the AB1 Electrosurgical System for Bronchoscopic Microwave Ablation of Lung Tissue (AB1MALT) - AB1MALT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients who:
- •1. Have signed informed consent.
- •2. Are >= 18 years old.
- •3. Have lung lesion(s)/nodule(s) which are histopathologically confirmed or are
- •highly suspicious for cancer and is a candidate for bronchoscopic microwave
- •ablation (as determined by a multi-disciplinary team (MDT) or tumour board).
- •4. Have medically inoperable soft tissue lung lesion(s) <= 20 mm (suspected or
- •confirmed malignancy), or a patient has elected not to have surgery /
- •alternative therapy.
- •5. Patient is a candidate for bronchoscopy under general anaesthesia.
- •6. Subject is willing and able to comply with the study protocol requirements.
- •7. 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: 1. 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 & laryngeal nerves)
- •or are <10 mm from the pleura. 2. Are assigned status 4 via ECOG (Eastern
- •Cooperative Oncology Group) classification. 3. Are pregnant or breast feeding,
- •as determined by standard site practices. 4. Have participated in an
- •investigational drug or device research study within 30 days of enrolment that
- •would interfere with this study. 5. Are scheduled for concurrent interventional
- •procedure for the target soft tissue lesion. 6. Have a physical or
- •psychological condition or other factor(s) that would impair study
- •participation or jeopardise the safety or welfare of the subject. 7. Have an
- •expected survival less than 6 months. 8. Have bleeding diathesis, uncorrectable
- •coagulopathy or platelet count <= 100 x 10* /L. 9. Have an implantable device,
- •including pacemakers or other electronic implants. 10. Have known pulmonary
- •hypertension (PASP [pulmonary artery systolic pressure] >50mmHg). 11. Who are
- •currently prescribed anticoagulants, clopidogrel or other platelet aggregation
- •inhibitors which can*t be stopped or temporarily withheld. 12. Any patient with
- •clinically significant interstitial lung disease in the zone of planned
- •ablation. 13. 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. 14. Subject had a prior
- •pneumonectomy.
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