An interventional study of Endobronchial Silicon Spigots in Pneumothorax, sponsored by Hangzhou Broncus Medical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.
Sponsored by Hangzhou Broncus Medical Co., Ltd. · Not applicable, Interventional, and Treatment
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.
Subjects must meet all of the following criteria to be enrolled:
Exclusion Criteria:
Subjects with any of the following conditions cannot be selected:
Contraindications for bronchoscopy:
All subjects will be assigned to the treatment group to receive the endobronchial silicon spigot treatment.
Device: Endobronchial Silicon Spigots
The 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.
Time frame: 7 days
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.
Time frame: 14 days
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.
Time frame: 14 days
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.
Time frame: 42 days
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.
Time frame: 28 days
Endobronchial spigots Removal Time
The time (in days) from successful placement of the endobronchial silicon spigots to successful removal of the endobronchial silicon spigots.
Time frame: 30 days
Technical Success Rate
The proportion of successful placements of the endobronchial silicon spigots into the responsible drainage bronchus out of the total number of operations.
Time frame: 30 days
Incidence of Treatment-Emergent Adverse Events
Record all adverse events during surgery and postoperative follow-up, assess the relatedness to the device itself and treatment, and calculate the incidence of device-related and surgical treatment-related adverse events and serious adverse events.
Time frame: 30 days
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Hangzhou Broncus Medical Co., Ltd.