Pneumothorax
Conditions
Keywords
Pneumothorax, spigots, air leakage, bronchial occlusion
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 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.
Interventions
DEVICEEndobronchial 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.
Sponsors
Hangzhou Broncus Medical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study is a single-arm trial, intending to enroll 10 subjects. All subjects will be assigned to the treatment group to receive the study treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must meet all of the following criteria to be enrolled: 1. Male or female, aged ≥18 years; 2. Patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days; 3. 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; 4. Voluntarily participate in this trial and sign an informed consent form.
Exclusion criteria
* Subjects with any of the following conditions cannot be selected: 1. Allergic to silicone materials; 2. 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. 3. Uncontrolled acute pulmonary infection or severe chronic infection at the intended occlusion lobes or segments; 4. Obvious hemodynamic instability or unstable respiratory failure; 5. The responsible bronchus cannot be determined by balloon detection; 6. The researcher believes that the patient has other conditions that are not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Occlusion Success Rate | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Occlusion Cure Rate | 14 days | 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. |
| Total Occlusion Cure Rate | 42 days | 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. |
| Chest Drainage Tube Removal Rate | 28 days | 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. |
| First Occlusion Success Rate | 14 days | 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. |
| Technical Success Rate | 30 days | The proportion of successful placements of the endobronchial silicon spigots into the responsible drainage bronchus out of the total number of operations. |
| Incidence of Treatment-Emergent Adverse Events | 30 days | 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. |
| Endobronchial spigots Removal Time | 30 days | The time (in days) from successful placement of the endobronchial silicon spigots to successful removal of the endobronchial silicon spigots. |
Countries
China
Contacts
Primary ContactLiheng Xie
Outcome results
None listed