Actively Recruiting
Exploratory Study to Evaluate Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for Refractory Pneumothorax
Led by Hangzhou Broncus Medical Co., Ltd. · Updated on 2024-08-15
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of single-use endobronchial silicon spigots to treat patients with refractory pneumothorax who continue to have air leaks despite standard drainage treatment. This exploratory clinical study aims to provide initial data on the use of this bronchial occlusion device and assess its preliminary effectiveness in closing air leaks in the lungs. All participants will receive treatment with the disposable endobronchial silicon spigot, which is made of implant-grade silicone and designed to temporarily block the target bronchus. The device is delivered via bronchoscope and biopsy forceps to the lung area causing the air leak, with position adjusted to seal the responsible bronchus. This single-group, single-center study enrolls about 10 patients and does not involve a comparison group. Participants will be monitored for outcomes such as success rates of bronchial occlusion at 7, 14, and 42 days, removal of chest drainage tubes, time until spigot removal, technical success, and any adverse events within 30 days. The study includes evaluations by bronchoscopy, clinical assessments, and safety monitoring over several weeks to gather data on the procedure's feasibility and safety.
CONDITIONS
Brief 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 who have persistent air leaks after at least 7 days of continuous chest drainage
- Assessed as suitable for selective bronchial occlusion by bronchoscopy, with the responsible bronchus identifiable by balloon detection
- Voluntary participation and signing of informed consent
You will not qualify if you...
- Allergy to silicone materials
- Contraindications for bronchoscopy such as recent myocardial infarction within 1 month, active massive hemoptysis, low platelet count (<20×10^9/L), pregnancy, severe heart or lung conditions, severe mental illness, or extreme systemic exhaustion
- Uncontrolled acute or severe chronic infection in the target lung lobes
- Obvious hemodynamic instability or unstable respiratory failure
- Inability to identify responsible bronchus by balloon detection
- Other conditions deemed unsuitable by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days
Participants receive the endobronchial silicon spigot treatment through a bronchoscopy procedure to occlude the responsible bronchus causing air leakage.
1 procedure visit and follow-up visits up to 30 days
Duration - Up to 42 days
Participants are monitored for treatment success, adverse events, and removal of the endobronchial spigots after treatment.
Multiple follow-up visits during 42 days
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
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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