NCT07136961进行中（未招募）不适用
Efficacy and Safety of Robotic-assisted Bronchoscopy Combined With the ICNVA Strategy in Biopsy of Peripheral Pulmonary Nodules: A Prospective, Single-center, Single-arm Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Tool-in-lesion rate
研究概览
简要总结
To assess the efficacy and safety of robotic-assisted bronchoscopy system (bronchial navigation and positioning device) combined with ICNVA strategy for peripheral pulmonary nodule biopsy through a prospective, single-center, single-arm study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ≥18 years old, and ≤75 years old, male or female;
- •Patients with peripheral lung lesions found by chest CT, whose diameter ≥ 6mm and < 3cm, who plan to undergo robotic-assisted bronchoscopic for pulmonary biopsy;
- •The patient voluntarily undergo bronchoscopy and meet the requirements for bronchoscopy;
- •Patients can understand the purpose of the trial, have good compliance with the examination and follow-up, voluntarily participate in the clinical trial and sign the informed consent.
排除标准
- •Patients with cardiovascular diseases, such as blood pressure instability, myocardial infarction or arrhythmia;
- •Patients with massive hemoptysis within two weeks;
- •Patients with severe pneumothorax and rib fracture;
- •Patients with serious infectious diseases, such as tuberculosis or AIDS;
- •Patients with severe abdominal aortic aneurysm or thoracic aortic aneurysm;
- •Participants who have participated in or are participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
- •Those who were not considered suitable for inclusion by the researchers.
结局指标
主要结局
Tool-in-lesion rate
时间窗: Perioperative/Periprocedural
次要结局
- Center Strike rate(Perioperative/Periprocedural)
- Tool-touch-lesion rate(Perioperative/Periprocedural)
- Successful diagnosis rate(Perioperative/Periprocedural)
- Lesion detection rate(Perioperative/Periprocedural)
- Bronchopulmonary hemorrhage rate(Perioperative/Periprocedural)
- Pneumothorax rate(Perioperative/Periprocedural)
- CT to Body divergence（CTBD）(Perioperative/Periprocedural)
- Successful operation rate(Perioperative/Periprocedural)
研究者
Shaohua Dai
M.D., Ph.D, Professor
The First Affiliated Hospital of Nanchang University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the LungLung CancerPulmonary NoduleNCT04182815Auris Health, Inc.691
招募中
不适用
Feasibility and Safety of Remote Robotic Bronchoscopy System in Diagnosis of Peripheral Pulmonary Lesions: a Multicenter, Randomized Controlled, Proof-of Concept TrialPulmonary NoduleNCT06613412Guangzhou Medical University10
终止
不适用
Robotic-assisted Bronchoscopy Under Moderate Sedation With PropofolNCT07006311University of Zurich10
招募中
不适用
RAB Versus Ultrathin Bronchoscopy With VBN in the Diagnosis of PPNsNCT06962436Shanghai Chest Hospital186
已完成
不适用
Fibreoptic Bronchoscopy Assisted Intubation During Noninvasive Positive Pressure VentilationRespiratory FailureNCT02462668Lingbo Nong106