Study to Assess the Safety and Effectiveness of Single-Use Endobronchial Silicon Spigots for Treating Persistent Pneumothorax

What this Trial Is About

Researchers are evaluating the feasibility and safety of single-use endobronchial silicon spigots to treat patients with refractory pneumothorax who continue to have air leaks despite standard drainage treatment. This exploratory clinical study aims to provide initial data on the use of this bronchial occlusion device and assess its preliminary effectiveness in closing air leaks in the lungs. All participants will receive treatment with the disposable endobronchial silicon spigot, which is made of implant-grade silicone and designed to temporarily block the target bronchus. The device is delivered via bronchoscope and biopsy forceps to the lung area causing the air leak, with position adjusted to seal the responsible bronchus. This single-group, single-center study enrolls about 10 patients and does not involve a comparison group. Participants will be monitored for outcomes such as success rates of bronchial occlusion at 7, 14, and 42 days, removal of chest drainage tubes, time until spigot removal, technical success, and any adverse events within 30 days. The study includes evaluations by bronchoscopy, clinical assessments, and safety monitoring over several weeks to gather data on the procedures feasibility and safety.

Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax