NCT04447482Unknown不适用
A Prospective, Randomized, Multi-center, Superiority Clinical Study to Evaluate the Effectiveness and Safety of Bronchoscopic Lung Biopsy Under the Guide of CT Stereotactic Auxiliary Equipment and Accessories
Shanghai Youhe Medical Technology Co., Ltd.4 个研究点 分布在 1 个国家目标入组 212 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
研究概览
简要总结
Evaluate results for participants with lung lesions randomized to either 4D Electromagnetic Navigation Bronchoscopy (4D-ENB) versus Conventional Bronchoscopy with Fluoroscopy for diagnostic biopsy and detection of lung cancer.
详细描述
The objective of this clinical trial is to evaluate the safety and efficacy results for two bronchoscopic biopsy techniques for sampling lung lesions: either image-guided electromagnetic navigation or conventional bronchoscopy with fluoroscopy. The diagnostic yield and adverse events of participants prospectively randomized to either arm will be evaluated. This is a prospective, randomized, multi-center study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be selected:
- •Be older than 18 (including 18) and younger than 75 (including 75);
- •The population with peripheral lung lesions detected in chest CT scanning and who require biopsy;
- •The subjects are willing to undergo bronchoscopy and meet the requirements for bronchoscopy;
- •The subjects or their guardians can understand the trial objective, volunteer to participate and sign the informed consent form.
排除标准
- •Subjects will be excluded if they meet any of the following criteria:
- •The patient is participating in another drug or medical device clinical trial (drug clinical trial within 3 months or medical device clinical trial within 1 month);
- •Women of childbearing age who have positive pregnancy test result and lactating women;
- •Allergic to anesthetics;
- •Bronchoscopy contraindications, including: active massive hemoptysis; recent myocardial infarction or unstable angina pectoris; severe heart and lung dysfunction; severe hypertension and arrhythmia; uncorrectable bleeding tendency (such as severe coagulation disorders, uremia and severe pulmonary hypertension); severe superior vena cava obstruction syndrome; suspected aortic aneurysm; multiple pulmonary bullae; systemically extreme exhaustion.
- •Visible intraluminal lesions found during bronchoscopy;
- •Patients with severe lung diseases (including: severe bronchodilatation, severe emphysema, etc.) and patients determined to be unsuitable for the examination by the investigators;
- •Patients with a pacemaker or defibrillator;
- •Patients who cannot cooperate with the doctor to complete bronchoscopy, such as patients with mental and neurological diseases, mental retardation and mental disorders;
- •Patients to whom bronchoscopy and bronchoscopic sampling are not applicable to diagnose the lesions, or other patients determined to be unsuitable for this trial by the investigators.
结局指标
主要结局
Evaluate the diagnostic rate of lung biopsies between the treatment group and the control group.
时间窗: 6 months.
Diagnostic rate is defined as the proportion of true positive and true negative.
次要结局
- Sampling success rate of the treatment group and the control group.(2 weeks.)
- Navigation success rate of 4D-ENB and biopsy accessories.(Duration of procedure, or up to 120 minutes.)
- Navigation time (time to find the lesions) of the treatment group and the control group.(Duration of procedure, or up to 120 minutes.)
- Total operation time of the treatment group and the control group.(Duration of procedure, or up to 120 minutes.)
- Device performance evaluation of CT Stereotactic Auxiliary Equipment and Accessories.(Duration of procedure, or up to 120 minutes.)
研究者
研究点 (4)
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