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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Endobronchial Silicon Spigots
  The single-use endobronchial silicon spigot is injection-molded from implant-grade silicone and has a solid conical body. The endobronchial silicon spigot is used for the temporary occlusion of the target bronchus. It is delivered to the target bronchus through a bronchoscope using biopsy forceps, and the position of the blocker is adjusted to occlude the responsible bronchus leading to the pleural air leakage.

Первичные конечные точки

• Total Occlusion Success Rate [Срок оценки: 7 days]

Вторичные конечные точки (7)

• First Occlusion Success Rate [Срок оценки: 14 days]
• First Occlusion Cure Rate [Срок оценки: 14 days]
• Total Occlusion Cure Rate [Срок оценки: 42 days]
• Chest Drainage Tube Removal Rate [Срок оценки: 28 days]
• Endobronchial spigots Removal Time [Срок оценки: 30 days]
• Technical Success Rate [Срок оценки: 30 days]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Subjects 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 balloon detection;
• Voluntarily participate in this trial and sign an informed consent form.

Критерии исключения

• Subjects 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 aneurysm, severe mental illness, and extreme systemic exhaustion, etc.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Fujian Medical University — Quanzhou

Идентификаторы

NCT: NCT06515015 · BC-I-ESS-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗