Computed Tomography (CT) Guided Lung Biopsy With Plug - Evaluation of Safety and Efficacy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Evaluate the rate of chest tube
研究概览
简要总结
Protocol Title:
Computed Tomography (CT) Guided Lung Biopsy with BioSentry Plug, Evaluation of Safety and Efficacy.
详细描述
Protocol Summary:
Prospective, randomized, controlled, unblinded, post-market, single-center clinical study
Objectives:
Patients treated with the BioSentry system will be compared to patients not treated with the BioSentry System (Control Group).
Primary Objective:
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
- 是
入选标准
- •Provide written informed consent prior to any study related procedure
- •Male or female, aged ≥18 years or older
- •Percutaneous transthoracic needle lung biopsy indicated
排除标准
- •There are no specific exclusion criteria for the study. All participants are evaluated by a pulmonologist prior to admission and determined eligible for the procedure.
研究组 & 干预措施
Plug Arm
Participants randomized for plug arm will be treated with a plug after CT guided is conducted.
干预措施: The BioSentry Tract Sealant System (Device)
Non Plug arm
No Intervention, i.a. CT guided biopsy without plug.
结局指标
主要结局
Evaluate the rate of chest tube
时间窗: 2 years
Evaluate the rate of chest tube placement after percutaneous transthoracic needle lung biopsy
次要结局
未报告次要终点
研究者
Haseem Ashraf
Associate professor, PhD
University Hospital, Akershus