NCT02066103已完成不适用
Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Treatment safety
研究概览
简要总结
Assess the safety and feasibility of local oncological drug delivery into the bronchial wall after recanalization of subjects with malignant airway obstruction. Safety and feasibility (technical success) will be assessed.
This localized delivery is intended as an adjunct therapy and all subjects will receive standard of care oncology therapy as determined by their treating physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Life expectancy of at least 12 weeks
- •Adequate bone marrow, liver, and renal function
- •Scheduled to undergo bronchoscopy for malignant airway obstruction as standard medical care
- •Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
- •Measurable disease with obstruction into the airway
- •Pathologically confirmed, unresectable primary or recurrent non-small cell lung cancer
- •Patients undergo recanalization procedure of tumor during bronchoscopy
- •Investigator is able to insert and deploy the Blowfish Catheter into the airway after recanalization
排除标准
- •Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
- •Pregnant or nursing female subjects, or female subjects of child bearing potential who refuse to take a pregnancy test prior to their enrollment in this study
- •Uncontrolled infection
- •Presence or recent history of any systemic disorder or conditions, such as:
- •uncontrolled hypertension
- •type 1 diabetes
- •severe pulmonary hypertension
- •acute kidney injury
- •stroke (within the last 6 month)
- •myocardial infarction (within the last 3 months)
- •Individuals with neurological, mental or psychiatric disorders
- •Concurrent participation in another study involving investigational drugs or investigational medical devices
- •Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
- •Known hypersensitivity to paclitaxel, Cremophor EL, or iodinated contrast media
- •Any serious, uncontrolled comorbidity or condition that an Investigator believes would interfere with the intent of the study or would make participation not in the best interest of the patient Intraoperative Exclusion Criteria
- •Use of pulmonary airway stents and/or ongoing or initiation of local external beam or brachytherapy radiation
- •Any intraoperative complications that per the investigator's judgment increase the risk to the patient.
研究组 & 干预措施
Treatment
Experimental
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Treatment safety
时间窗: 12 weeks
Adverse Events (AEs), Serious Adverse Events (SAEs), and all Unanticipated Adverse Device Effects (UADEs)
Technical success
时间窗: procedure day
Device deployment and infusion success
次要结局
- Quality of Life(12 weeks)
- Airway patency improvements(6 weeks)
研究者
研究点 (3)
Loading locations...
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