About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Allergic to silicone materials;
Myocardial infarction within the past month;
Active massive hemoptysis;
Platelet count <20×10^9/L;
Trial design
Treatments tested in this trial
- Endobronchial Silicon Spigots