Effect of Autologous Blood Patch Injection Versus BioSentry Hydrogel Tract Plug in the Reduction of Pneumothorax Risk Following Lung Biopsy Procedures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 3
- 主要终点
- the Rate of Pneumothorax
研究概览
简要总结
The purpose of this study is to compare two methods that are currently used at the end of a CT guided lung biopsy to close the hole on the surface of the lung in order to minimize the chance of air leaking out of the hole. The two techniques consist of either injecting a very small amount of your the blood called a blood patch into the biopsy hole or injecting a gel-based FDA approved artificial plug called BioSentry that will eventually get absorbed into the body.
详细描述
This study will determine the rate of all pneumothoraces and those pneumothoraces requiring treatment following percutaneous lung biopsy in patients who have received ABPI or BioSentry at the end of the biopsy procedure. The data collected will be used to determine if there is equal effectiveness in the reduction of pneumothorax rates from both interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •≥18 years of age
- •Referred for CT guided biopsy of lung lesion
- •Target lesion of any size
- •Target lesion located 1.5 cm or more away from visceral pleura based on the needle path
- •Skin thickness ≤7 cm (from skin to pleura)
- •Needle path without transgression of pleural fissure bleb, or bulla is possible
- •Coaxial biopsy technique using Angiotech 19-Gauge introducer needle
- •Needle length ≤15
排除标准
- •Passage through non-aerated lung or tissue
- •More than 1 biopsy on the same side requiring more than 1 pleural puncture
- •History of prior ipsilateral lung interventions including:
- •Chest tube placement
- •Pleurodesis
- •Radiation treatment
结局指标
主要结局
the Rate of Pneumothorax
时间窗: 2 hours post procedure
within 2 hours following biopsy. Pneumothorax is observed on post procedure CT scan or on follow-up chest radiographs while the patient is in the recovery room, according to standard of care.
次要结局
未报告次要终点