A Real-World Case Study Evaluating the Efficacy and Safety of Bronchial Navigation Localization Device-Assisted Cryobiopsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- overall diagnostic yield
研究概览
简要总结
The goal of this clinical trial is tois to assess the effectiveness and safety of RBS (Robotic Bronchoscopy System)-assisted cryobiopsy in real-world clinical settings in adult patients (aged ≥18 years) with suspected pulmonary lesions requiring diagnostic bronchoscopic evaluation. The main questions it aims to answer are:
Does RBS-assisted cryobiopsy improve diagnostic yield compared to conventional non-RBS-guided cryobiopsy? Is RBS-assisted cryobiopsy associated with a lower incidence of procedure-related complications (e.g., bleeding, pneumothorax) compared to conventional methods? Researchers will compare the RBS group (patients undergoing RBS-assisted cryobiopsy) with the control group (patients undergoing cryobiopsy with conventional navigation techniques, such as ENB, VBN) to evaluate differences in diagnostic accuracy and safety outcomes.
Participants will:
Provide informed consent for bronchoscopic cryobiopsy. Undergo pre-procedure imaging and clinical evaluation. Receive either RBS-assisted or conventional cryobiopsy based on clinical indication and operator discretion.
Be monitored for immediate and delayed complications .
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
- •Inclusion Criteria:
- •Patients are eligible for inclusion if they meet all of the following criteria:
- •Age ≥18 years and ≤75 years, with no gender restrictions;
- •Presence of a peripheral lung lesion on chest CT
- •Patients voluntarily agree to undergo bronchoscopy and meet the requirements for the procedure;
- •patients are capable of understanding the purpose of the trial, demonstrate good compliance with the examinations and follow-up, voluntarily participate in the clinical trial, and sign an informed consent form.
排除标准
- •Patients who meet any of the following criteria will be excluded from this study:
- •Presence of contraindications for bronchoscopy, including: active massive hemoptysis; recent myocardial infarction or unstable angina; severe cardiac or pulmonary dysfunction; severe hypertension and arrhythmias; uncorrectable bleeding tendencies or severe coagulation disorders (such as platelet count <60×10^9/L), uremia; severe pulmonary artery hypertension; severe superior vena cava syndrome; intracranial hypertension; acute cerebrovascular events; aortic dissection or aneurysm; multiple bullae; extreme systemic exhaustion;
- •Female patients who are breastfeeding, pregnant, or planning pregnancy;
- •Patients with electromagnetic active implantable medical devices;
- •Subjects allergic to anesthetics; or with a history of multiple severe allergies, hereditary allergy history;
- •Those who have participated in or are currently participating in drug clinical trials within 3 months before screening, or have participated in other medical device clinical trials within 30 days;
- •Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
- •Exclusion Criteria:
研究组 & 干预措施
RBS group
Patients in RBS group would undergo cryobiopsy with the help of RBS
干预措施: unicorn robotic bronchoscopy system (Procedure)
Control group
Patients in control group would undergo cryobiopsy with the help of conventional navigation technology.
干预措施: Conventional navigation bronchoscopy (Procedure)
结局指标
主要结局
overall diagnostic yield
时间窗: 6 months after biopsy
Overall diagnostic yield was considered as the primary outcome, defined as the number of cases in which the diagnosis of bronchoscopy matched the final diagnosis, divided by the total number of completed cases during follow-up. A lesion was considered malignant if tumor cells were found in histological and/or cytological specimens. It was considered benign if pathological evaluation showed specific benign pathology and/or non-specific benign lesions confirmed by MDT discussion.
次要结局
- Navigation success rate(During the bronchoscopy)
研究者
Li Shiyue
professor
Guangzhou Medical University