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Recruiting NCT06515015

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

No phase Interventional Pneumothorax

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endobronchial Silicon Spigots.
Who it may be relevant to
Registry conditions: Pneumothorax. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Total Occlusion Success Rate [Time frame: 7 days]
Secondary outcome measures (7)
  • First Occlusion Success Rate [Time frame: 14 days]
  • First Occlusion Cure Rate [Time frame: 14 days]
  • Total Occlusion Cure Rate [Time frame: 42 days]
  • Chest Drainage Tube Removal Rate [Time frame: 28 days]
  • Endobronchial spigots Removal Time [Time frame: 30 days]
  • Technical Success Rate [Time frame: 30 days]
  • Incidence of Treatment-Emergent Adverse Events [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Fujian Medical University — Quanzhou

Identifiers

NCT: NCT06515015 · BC-I-ESS-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗