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Tests treatment safety and results for Pneumothorax
Official title Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
ClinicalTrials.gov ID: NCT06515015
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet all of the following criteria to be enrolled:
- Male or female, aged ≥18 years;
- Patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days;
- After evaluation by the researcher, the subject is feasible for the bronchoscopic procedure of selective bronchial occlusion to treat refractory...
- Voluntarily participate in this trial and sign an informed consent form.
You likely can't join if
- people with any of the following conditions cannot be selected:
- Allergic to silicone materials;
- Contraindications for bronchoscopy:
- Myocardial infarction within the past month;
- Active massive hemoptysis;
- Platelet count \<20×10\^9/L;
See the full eligibility criteria
- people must meet all of the following criteria to be enrolled:
- Male or female, aged ≥18 years;
- Patients with various types of pneumothorax who still have persistent air leaks after continuous intercostal drainage for 7 days;
- 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...
- Voluntarily participate in this trial and sign an informed consent form.
- people with any of the following conditions cannot be selected:
- Allergic to silicone materials;
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Quanzhou, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Quanzhou, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.