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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | All subjects will be assigned to the treatment group to receive the endobronchial silicon spigot treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial Silicon Spigots | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled:
Exclusion Criteria:
Subjects with any of the following conditions cannot be selected:
Allergic to silicone materials;
Contraindications for bronchoscopy:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liheng Xie | Contact | +86-13916444591 | medicalaffairs@broncuschina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yiming Zeng, M.D | The Second Affiliated Hospital of Fujian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Fujian Medical University | Recruiting | Quanzhou | Fujian | 362018 | China |
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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.
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|
| 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 |
| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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