Exploratory, Single-Group, Single-Center Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Total Occlusion Success Rate
研究概览
简要总结
Study Objective: To evaluate the feasibility and safety of the disposable endobronchial silicon spigots for treating refractory pneumothorax and to preliminarily assess its efficacy, providing domestic experience for the development and clinical application of bronchial occlusion.
Study Population: Patients intended to receive selective bronchial occlusion technology for the treatment of refractory pneumothorax.
Sample Size: This study is a preliminary exploration of the application value of the disposable endobronchial silicon spigots occlusion technology in refractory pneumothorax. The sample size has not been strictly calculated, and it is expected to include 10 patients.
Study Design: This study is an exploratory, single-group, single-center clinical 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
- Treatment
- 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
- •Subjects must meet all of the following criteria to be enrolled:
- •Male or female, aged ≥18 years;
- •Patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days;
- •After evaluation by the researcher, the subject is feasible for the bronchoscopic procedure of selective bronchial occlusion to treat refractory pneumothorax, and the responsible bronchus can be determined by the balloon detection;
- •Voluntarily participate in this trial and sign an informed consent form.
排除标准
- •Subjects with any of the following conditions cannot be selected:
- •Allergic to silicone materials;
- •Contraindications for bronchoscopy:
- •Myocardial infarction within the past month;
- •Active massive hemoptysis;
- •Platelet count <20×10^9/L;
- •Pregnancy;
- •Malignant arrhythmias, unstable angina, severe cardiopulmonary dysfunction, hypertensive crisis, severe pulmonary arterial hypertension, intracranial hypertension, acute cerebrovascular events, aortic dissection, aortic aneurysm, severe mental illness, and extreme systemic exhaustion, etc.
- •Uncontrolled acute pulmonary infection or severe chronic infection at the intended occlusion lobes or segments;
- •Obvious hemodynamic instability or unstable respiratory failure;
- •The responsible bronchus cannot be determined by balloon detection;
- •The researcher believes that the patient has other conditions that are not suitable for inclusion in this study.
结局指标
主要结局
Total Occlusion Success Rate
时间窗: 7 days
The percentage of subjects who are successfully\* occluded after temporary embolization with endobronchial silicon spigots (including second occlusion) out of the total number of subjects receiving bronchial blocker treatment.
次要结局
- First Occlusion Success Rate(14 days)
- Endobronchial spigots Removal Time(30 days)
- Incidence of Treatment-Emergent Adverse Events(30 days)
- Chest Drainage Tube Removal Rate(28 days)
- Total Occlusion Cure Rate(42 days)
- First Occlusion Cure Rate(14 days)
- Technical Success Rate(30 days)