NL-OMON56952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 in Surgical Candidates (AB1MALTISC) - AB1MALTISC
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. Subject is willing and able
- •to comply with all aspects of the treatment and evaluation schedule. 3. Are >=
- •18 years old. 4. Have lung lesion(s)/nodule(s) which are histopathologically
- •confirmed as cancer. 5. 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 6. Are candidates for surgical
- •resection as determined by a multi-disciplinary team (MDT) or tumour board. 7.
- •> 10 mm of tumour-free lung parenchyma between target tumour and pleura or
- •fissure. 8. Subject is willing and able to comply with the study protocol
- •requirements. 9. 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. 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).
- •2. Are pregnant or breast feeding, as determined by standard site practices. 3.
- •Have participated in an investigational drug or device research study within 30
- •days of enrolment that would interfere with this study. 4. Have a physical or
- •psychological condition that would impair study participation or jeopardise the
- •safety or welfare of the subject. 5. Have an expected survival less than 12
- •months. 6. Have bleeding diathesis, uncorrectable coagulopathy, or platelet
- •count <= 100 x 10* /L. 7. Have an implantable device, including pacemakers or
- •other electronic implants. 8. Have known pulmonary hypertension (PASP
- •[pulmonary artery systolic pressure] >50mmHg). 9. Who are currently prescribed
- •anticoagulants, clopidogrel or other platelet aggregation inhibitors which
- •can*t be stopped or temporarily withheld. 10. Subject had a prior
- •pneumonectomy. 11. Diagnosis of Small Cell Lung Cancer. 12. Any patient with
- •clinically significant interstitial lung disease in the zone of planned
- •ablation. 13. Subject had a therapeutic intervention (e.g., SBRT) within same
- •lobe as the target lesion. 14. Subjects currently undergoing or underwent
- •chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3
- •months of planned Study procedure.
研究者
相似试验
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)lung carcinoma100729901002910710038737lung cancerNL-OMON56949Creo Medical Limited10
进行中（未招募）
不适用
Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)Severe Degenerative Mitral Regurgitation due to Mid-segment Posterior Leaflet ProlapseDRKS00022786Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,42
招募中
不适用
Assessment of the safety and performance of the HARPOON* Beating Heart Mitral Valve Repair System; a multi-center post-market study (The ASCEND Study).NL-OMON50870HARPOON Medical, an indirect wholly-owned subsidiary of Edwards Lifesciences Corporation20
招募中
不适用
Safety and Technical Performance Evaluation of the Emboliner Embolic Protection Device: A New Zealand ExperienceTranscatheter aortic valve replacementEmbolic protectionCardiovascular - Other cardiovascular diseasesACTRN12622000473763Emboline, Inc.20
已完成
不适用
The verification study for safety evaluation of bamboo cellulose nanofiber long-term administration in human: an open-label trialHealthy adultsJPRN-UMIN000024030ORTHOMEDICO, Inc.20