ACTRN12618001748202招募中未知
Vapor Ablation for Localized Cancer Lesions of the Lung – A Clinical Feasibility Treat-and-Resect Study (VAPORIZE)
ptake Medical Inc.0 个研究点目标入组 6 人开始时间: 2018年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 6
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Age: equal to or greater than 18 years old
- •2.Non-small cell lung cancer tumor(s) equal to or less than 2cm in diameter (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection
- •Metastatic lung tumor(s) equal to or less than 2cm suitable for resection
- •3.Suitable candidate for resection per standard of practice
- •4.Microscopic proof of malignancy obtained.
- •5.Location of tumor:
- •a.In periphery of lung (outermost one third)
- •b.Anticipation that resection would remove all gross tumor and ablation with grossly negative margins
- •c.Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan
- •6.Signed informed consent
排除标准
- •1.Centralized tumor not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)
- •2.Carcinoid lung tumors
- •3.Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion
- •4.Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted
- •5.Requirement for supplemental oxygen at rest or exercise
- •6.Hospitalization for cardiac disease within the preceding 6 months
- •7.Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN)
- •8.Serum creatinine > 2 mg/dl
- •9.Recent infection (within 30 days)
- •10.Receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent)
- •11.Pre-existing implants within the airways that impede navigation to the target lesion
- •12.Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
- •13.Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days, post-procedure.
- •14.Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives
- •15.Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
研究者
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