Using single-use silicon spigots to treat persistent pneumothorax
Exploratory, Single-Group, Single-Center Clinical Study to Evaluate the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
This study is testing if using single-use silicon spigots can help people with stubborn air leaks in their lungs feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hangzhou Broncus Medical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Quanzhou, Fujian) |
| Trial ID | NCT06515015 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of using disposable endobronchial silicon spigots for patients suffering from refractory pneumothorax, which is characterized by persistent air leaks despite standard treatment. The research involves a single-group, single-center design and aims to preliminarily assess the efficacy of this innovative bronchial occlusion technology. A total of 10 patients will be included, all of whom must meet specific eligibility criteria related to their condition and treatment history.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with persistent air leaks from pneumothorax after 7 days of intercostal drainage.
Not a fit: Patients with silicone allergies or contraindications for bronchoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with refractory pneumothorax.
How similar studies have performed: This approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Quanzhou, Fujian
- The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Yiming Zeng, M.D — The Second Affiliated Hospital of Fujian Medical University
- Study coordinator: Liheng Xie
- Email: medicalaffairs@broncuschina.com
- Phone: +86-13916444591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.