DRKS00032463尚未招募Unknown
A prospective, single-center investigation of the safety and feasibility of a novel Microwave Ablation System
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Subject has ASA < 4
- •--Subject is not a candidate for surgical resection of lung tumor (e.g. subject has medically inoperable lung cancer based on subject condition or tumor/disease characteristic) or patient refuses surgery
- •--Subject with a solid or semi-solid primary or secondary lung tumor of 0.8 -2.5 cm in largest diameter
- •--Subject has ECOG score < 2
- •--Subject has a confirmed diagnosis of Stage I-IIIA lung cancer with no evidence of nodal disease OR oligometastatic disease with secondary lung tumors (e.g., a primary cancer that developed at other places in the body or other parts of the lungs and metastasized to the lung where intervention is considered)
- •--Subject is a candidate for an elective bronchoscopy procedure under general anesthesia
- •--Target lesion is located in bronchial generation 3+ (segmental or beyond), with the trachea representing generation 0 as assessed on pre-procedure CT scan
- •--Subject is willing and able to provide written informed consent
- •--Subject is willing and able to comply with the study protocol requirements
排除标准
- •--Subject is unable to have intravenous contrast injection
- •--Baseline FEV1 < 40% and/or DLCO < 40% if clinically relevant per investigator assessment (e.g. represents risk to subjects undergoing procedure)
- •--Subject had any COPD exacerbation within 6 weeks of procedure
- •--Subject had a prior surgical procedure or therapeutic intervention (e.g. SBRT) within same lobe as the lesion
- •--Target lesion edge is within 1 cm of critical structures (e.g. esophagus, heart, aorta, or major vasculature) or within 0.5 cm of non-fissure parietal/visceral pleura
- •--Subject on a medication that interferes with clotting, including but not limited to Coumadin, Lovenox, or Plavix that cannot be stopped at least 7 days prior to the procedure and at least 3 days after procedure
- •--Subjects with Creatinine levels > 2.0
- •--Subjects with platelet count < 80,000
- •--Subjects with documented history of CHILD-PUGH Class B or Class C liver disease
- •--Subject has a planned therapeutic intervention (e.g. chemotherapy) for a malignant condition post-procedure
- •--Clinically significant pulmonary fibrosis or interstitial lung disease in target region expected to interfere with the planned ablation zone per investigator assessment
- •--Lesion has significant necrosis, and which may disrupt planned ablation zone per investigator assessment. Note – if significant necrosis or cavitation is noted during the procedure but prior to attempted probe placement, the subject will be excluded.
- •--Patient has nodal disease confirmed through invasive or image-based staging per investigator assessment precluding surgical resection or neoadjuvant therapy will be administered prior to the study procedure or planned resection. Note – if unexpected nodal disease is detected during the staging procedure conducted prior to use of the Investigational device during the study procedure; the subject may be excluded.
- •--Clinically significant emphysematous disease such as bulla/blebs in the same lobe as the target lesion or per Investigator assessment
- •--Subject with uncorrectable coagulopathy, bleeding or platelet disorders, or history of major bleeding with bronchoscopy
- •--Subject had a prior pneumonectomy
- •--Subject has clinically suspected or documented pulmonary hypertension
- •--Subject had a therapeutic intervention (e.g. SBRT) within same lobe as the target lesion
- •--Subject presents with documented life-threatening comorbidity that may increase risk of bronchoscopic procedure, including but not limited to Congestive Heart Failure or any type of Myocardial infarction (within 3 months of the procedure)
- •--Subjects currently undergoing or underwent chemotherapy, systemic immunosuppressive treatment or radiotherapy within 3 months of planned Study procedure
- •--Patients with recent pulmonary infection requiring antibiotics or hospitalization, or clinically relevant infectious disease within 30 days of the study procedure.
- •--Patient has active COVID-19 infection or post-COVID induced lung changes on CT which are clinically significant per investigator assessment
- •--Participation in any other interventional clinical study within 30 days prior of screening that interferes with or may confound safety or feasibility assessments
- •--Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements --
- •--Subject with any electronic implantable devices, such as pacemakers
- •--Subject is pregnant, suspected to be pregn
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