Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
NCT Number: NCT06515015
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pneumothorax
Interventions: DEVICE: Endobronchial Silicon Spigots
Sponsor: Hangzhou Broncus Medical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08
Locations: The Second Affiliated Hospital of Fujian Medical University, Quanzhou, Fujian, 362018, China

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 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.

Primary Outcome Measures: 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., 7 days
Secondary Outcome Measures: 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., 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., 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., 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., 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., 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., 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., 30 days