Transbronchial Lung Biopsy Guided by Electromagnetic Navigation Bronchoscopy: A Prospective, Randomized, Multicenter, Superiority Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 226
- 试验地点
- 8
- 主要终点
- Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB
研究概览
简要总结
The purpose of this study is to evaluate the performance and safety of electromagnetic navigation bronchoscopy (ENB) system and system kit (iLungTM SuperNavigator) .
详细描述
This is prospective, randomized, multicenter, superiority study. 8 top centers in China was chosen. Subject which has peripheral lung lesions (PLLs) detected by chest CT scan, requires biopsy diagnosis, and meets all inclusion and exclusion criteria, will be included in this trial. Firstly physician determines the lesion biopsied, then the subject will be randomized to experimental or control group. The experimental group is treated with ENB guided transbronchial lung biopsy (TBLB)(ENB-TBLB): Under ENB guidance, the location sensor reaches the edge of the lesion, and X-ray is used for actual distance confirmation, if physician determines the distance is enough for biopsy, TBLB will be conducted. The control group will be treated with TBLB using X-ray guidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •18 years and older;
- •Subject presents with PLL(s) detected by chest CT scan and biopsy diagnosis is needed;
- •Subject is willing to receive bronchoscopy voluntarily, and meets relevant requirements;
- •Subject or their guardian understands the purpose of this trial, and willing to participate in the trial voluntarily and sign Informed Consent Form (ICF).
排除标准
- •Subject has participated in a drug or device study (drug study within 3 months or device study within 1 month);
- •Female subject who is pregnant or nursing;
- •Allergic to anesthetic;
- •Bronchoscopy contraindications, include: Active hemoptysis; Newly developed myocardial infarction or unstable angina attack; Severe cardiac and pulmonary dysfunction; Severe hypertension and arrhythmia; Uncorrectable bleeding tendency (Such as severe clotting dysfunction, uremia, and severe pulmonary hypertension, etc.); Severe superior vena cava obstructive syndrome; Suspected aortic aneurysm; Multiple lung bullae; Extremely exhausted systemic conditions;
- •Subject with serious lung disease (Such as: severe bronchiectasis, severe emphysema, etc) ,which investigator considers not appropriate for this examination;
- •Subject with implanted pacemaker or defibrillator;
- •Lack of patient cooperation for bronchoscopy, such as patient with mental disorders, dysgnosia, psychological disorder etc;
- •Conditions investigator considers not appropriate for this trial.
结局指标
主要结局
Compare the diagnostic yield of ENB-TBLB with that of X-ray-TBLB
时间窗: Up to 6 months
Diagnostic yield = Lesions with definitive diagnosis /total lesions with biopsies. Comment: Lesions with definitive diagnosis: 1. Biopsy pathologic results show as benign or malignant lesion (fungi, tuberculosis, or nodule disease,etc.); 2. Biopsy pathologic results are abnormal lung tissue, but through later diagnosis, treatment and other observation measures, the lesion is proved to be benign; 3. When the patient cannot be diagnosed after a 6-month following-up, a CT or enhanced CT scan is needed and the physician make a final diagnosis based on the scan results.
次要结局
- Incidence of navigation success(At 1 day of ENB procedure)
- Navigation time(At 1 day of ENB or X-ray procedure)
- Evaluate the user satisfaction of ENB system and system kit(At 1 day of ENB procedure)
- The adverse events and device defects related to the ENB system and system kit(Up to 3 days)
- Lesion detection rate(About 3-7days after ENB or X-ray procedure)