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.
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.
Allergic to silicone materials;
Myocardial infarction within the past month;
Active massive hemoptysis;
Platelet count <20×10^9/L;
Single group
Endobronchial Silicon Spigots
DeviceThe single-use endobronchial silicon spigot is injection-molded from implant-grade silicone and has a solid conical body. The endobronchial silicon spigot is used for the temporary occlusion of the target bronchus. It is delivered to the target bronchus through a bronchoscope using biopsy forceps, and the position of the blocker is adjusted to occlude the responsible bronchus leading to the pleural air leakage.
Total Occlusion Success Rate
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.
First Occlusion Success Rate
The percentage of subjects who are successfully occluded after the first endobronchial silicon spigots treatment out of the total number of subjects receiving endobronchial silicon spigots treatment; if a second occlusion is received within 7 days after surgery, it is not counted as a first occlusion success.
First Occlusion Cure Rate
The percentage of subjects whose chest drainage tube completely stops leaking air within 14 days after the first endobronchial silicon spigots treatment out of the total number of subjects receiving endobronchial silicon spigots treatment; if a second occlusion is received within 14 days after surgery, it is not counted as a first occlusion cure.
Total Occlusion Cure Rate
The percentage of subjects whose chest drainage tube completely stops leaking air within 14 days after endobronchial silicon spigots treatment (including second occlusion) out of the total number of subjects receiving endobronchial silicon spigots treatment.
Chest Drainage Tube Removal Rate
The percentage of subjects who successfully remove the chest drainage tube within 28 days after endobronchial silicon spigots treatment (including second occlusion) out of the total number of subjects receiving endobronchial silicon spigots treatment.
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