NCT00562302已完成3 期
A Prospective, Randomized, Multi-centered Safety and Efficacy Evaluation of the Bio-Seal Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy
Angiotech Pharmaceuticals36 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2005年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 339
- 试验地点
- 36
- 主要终点
- Incidence Rate of Treatment Success
研究概览
简要总结
BS-1053 A Prospective Randomized Multi-Centered Safety and Efficacy Evaluation of the Bio-Seal Biopsy Track Plug for Reducing Pneumothorax Rates Post Lung Biopsy Procedures
详细描述
This is a multi-centered, randomized trial in patients receiving lung biopsies. Patients will be randomized to either receive or not receive a Bio-Seal Biopsy Track Plug after a lung biopsy per standard hospital protocol. This study is designed to demonstrate safety and efficacy of the Bio-Seal Biopsy Track Plug in reducing pneumothorax rates post lung biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •The patient must meet all medical conditions for lung biopsy;
- •The patient must be at least 18 years of age;
- •The patient, or legal representative, must understand and provide written consent for the procedure;
- •The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.
排除标准
- •Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;
- •Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
- •Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.
- •Patients who are uncooperative or cannot follow instructions.
- •Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.
结局指标
主要结局
Incidence Rate of Treatment Success
时间窗: 30 days
Treatment success was defined as the absence of a pneumothorax at each of the three follow-up time periods (0-60 minutes, 24 hours and 30 days).
次要结局
- Incidence of Chest Tube Placement(30 days)
- Time to Ambulation(30 days)
- Incidence of Hospital Admissions for Pneumothorax(30 day)
- Incidence of Adverse Events Related to the Procedure and Device Effects(30 Day)
- Number of Participants With Additional Chest X-rays Needed(30 day)
- Participants Discharged Beyond Hospital's Standard of Care(30-day)
- Incidence of Adverse Events(30 days)
研究者
研究点 (36)
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