Clinical trial NCT06515015: Evaluation of the Feasibility, Safety, and Efficacy of Single-use Endobronchial Silicon Spigots for the Treatment of Refractory Pneumothorax
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumothorax
Keywords: Pneumothorax
spigots
air leakage
bronchial occlusion
Lead sponsor: Hangzhou Broncus Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a single-arm trial, intending to enroll 10 subjects. All subjects will be assigned to the treatment group to receive the study treatment.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Total Occlusion Success Rate
timeFrame: 7 days
Secondary outcomes:
measure: First Occlusion Success Rate
timeFrame: 14 days
measure: First Occlusion Cure Rate
timeFrame: 14 days
measure: Total Occlusion Cure Rate
timeFrame: 42 days
measure: Chest Drainage Tube Removal Rate
timeFrame: 28 days
measure: Endobronchial spigots Removal Time
timeFrame: 30 days
measure: Technical Success Rate
timeFrame: 30 days
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: The Second Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The Second Affiliated Hospital of Fujian Medical University
name: Yiming Zeng, M.D
role: PRINCIPAL_INVESTIGATOR
References: