Actively Recruiting
Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Led by Hangzhou Broncus Medical Co., Ltd. · Updated on 2024-08-15
10
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Patients with pneumothorax and persistent air leaks after continuous intercostal drainage for 7 days
- Feasible for the bronchoscopic selective bronchial occlusion procedure with responsible bronchus identified by balloon detection
- Voluntarily agree to participate and sign informed consent
You will not qualify if you...
- Allergy to silicone materials
- Contraindications for bronchoscopy including myocardial infarction within past month, active massive hemoptysis, platelet count less than 20x10^9/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, or extreme systemic exhaustion
- Uncontrolled acute pulmonary infection or severe chronic infection at intended occlusion sites
- Obvious hemodynamic instability or unstable respiratory failure
- Responsible bronchus cannot be determined by balloon detection
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362018
Actively Recruiting
Research Team
L
Liheng Xie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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