Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 691
- 试验地点
- 19
- 主要终点
- Incidence of device or procedure related complications
研究概览
简要总结
This study is designed to evaluate clinical safety and diagnostic accuracy of the robotic-assisted bronchoscopy with biopsy performed with the Monarch™ Endoscopy Platform in a broad range of patients with pulmonary lesions.
详细描述
Despite technological advancements in guided bronchoscopy such as electromagnetic navigation bronchoscopy and radial probe endobronchial ultrasound, successful biopsy of peripheral pulmonary lesions remains a challenge due to a number of factors, one of which may be the ability to gain access to peripheral lesions due to the size and maneuverability of conventional bronchoscopes. The diagnostic yield of conventional bronchoscopic approaches for peripheral lesions remains suboptimal.
A novel robotic assisted bronchoscopy procedure now exists for patients with lung nodules. This procedure is performed using the Monarch™ platform (Auris Health, Inc., Redwood City, CA). This study is expected to enroll up to 1200 patients at up to 30 investigative sites.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 21 years of age;
- •Capable and willing to give informed consent;
- •Acceptable candidate for an elective, non-emergent bronchoscopic procedure;
- •Lung lesions, 8 mm to 50 mm in size, requiring bronchoscopic diagnosis which were identified on thin slice CT scan within 28 days of the intended bronchoscopy
排除标准
- •Medical contraindication to bronchoscopy as assessed by the investigator
- •Presence of uncorrectable bleeding disorders
- •Medical devices interfering with electro-magnetic navigation, including but not limited to pacemaker
- •Patients with the target lesion having endobronchial involvement seen on chest CT
- •Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure,
- •Participation in any other clinical trial within 30 days of enrollment that would interfere with this study;
- •Uncontrolled or irreversible coagulopathy;
- •Female subjects who are pregnant or nursing at the time of the procedure or those of child-bearing potential refusing a pregnancy test prior to the procedure;
- •CT scan done greater than 28 days before the bronchoscopy procedure.
结局指标
主要结局
Incidence of device or procedure related complications
时间窗: up to 7 days post procedure
The primary endpoint is a composite that includes pneumothorax requiring intervention rated as \> Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE) scale, bleeding requiring medical intervention, rated as \> Grade 1 according to the CTCAE scale, and respiratory failure, rated as \> Grade 3 according to the CTCAE scale.
次要结局
- Total procedure time(During the procedure)
- Rate of conversion to conventional bronchoscopic procedure(During the procedure)
- Rate of device or procedure related complications(up to 7 days post procedure)
- Sensitivity for malignancy(up to 24 months post procedure)
- Rate of post-bronchoscopy infections(up to 7 days post-procedure)
- Rate of adverse events unrelated to device or procedure(up to 7 days post procedure)
- Rate of all pneumothoraxes(up to 7 days post procedure)
- Stage at diagnosis(up to 24 months post procedure)
- Diagnostic yield(up to 24 months post procedure)