Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax

Launched by HANGZHOU BRONCUS MEDICAL CO., LTD. · Jul 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients with a condition called refractory pneumothorax, which is when air leaks into the space around the lungs and does not improve with standard treatments. The study aims to assess whether single-use silicone spigots, a type of device used to block the air leak, are safe and effective for this condition. The researchers are looking for about 10 participants who are at least 18 years old and have persistent air leaks despite receiving treatment for at least a week.

To join the trial, candidates must have specific types of pneumothorax and be able to undergo a procedure to identify the source of the air leak. Certain health conditions, like severe heart issues or active infections, will prevent someone from participating. Those who do take part can expect to receive treatment using the new silicone spigots and will be monitored closely for safety and effectiveness. This study represents an important step in developing new ways to help patients with this challenging condition.

Gender

ALL

Eligibility 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.