Status:
RECRUITING
Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Lead Sponsor:
Hangzhou Broncus Medical Co., Ltd.
Conditions:
Pneumothorax
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 domesti...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06515015
Start Date
August 1 2024
End Date
August 1 2026
Last Update
August 15 2024
Active Locations (1)
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1
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362018