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

Not Applicable

Recruiting

• Conditions: Pneumothorax
• Interventions: Device: Endobronchial Silicon Spigots

• Registration Number: NCT06515015
• Lead Sponsor: Hangzhou Broncus Medical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Endobronchial Silicon Spigots	All subjects will be assigned to the treatment group to receive the endobronchial silicon spigot treatment.

Primary Outcome Measures

Name	Time	Method
Total Occlusion Success Rate	7 days	The percentage of subjects who are successfully\* occluded after temporary embolization with endobronchial silicon spigots (including second occlusion) out of the total number of subjects receiving bronchial blocker treatment.

Secondary Outcome Measures

Name	Time	Method
First Occlusion Success Rate	14 days	The percentage of subjects who are successfully occluded after the first endobronchial silicon spigots treatment out of the total number of subjects receiving endobronchial silicon spigots treatment; if a second occlusion is received within 7 days after surgery, it is not counted as a first occlusion success.
Endobronchial spigots Removal Time	30 days	The time (in days) from successful placement of the endobronchial silicon spigots to successful removal of the endobronchial silicon spigots.
Incidence of Treatment-Emergent Adverse Events	30 days	Record all adverse events during surgery and postoperative follow-up, assess the relatedness to the device itself and treatment, and calculate the incidence of device-related and surgical treatment-related adverse events and serious adverse events.
Chest Drainage Tube Removal Rate	28 days	The percentage of subjects who successfully remove the chest drainage tube within 28 days after endobronchial silicon spigots treatment (including second occlusion) out of the total number of subjects receiving endobronchial silicon spigots treatment.
Total Occlusion Cure Rate	42 days	The percentage of subjects whose chest drainage tube completely stops leaking air within 14 days after endobronchial silicon spigots treatment (including second occlusion) out of the total number of subjects receiving endobronchial silicon spigots treatment.
First Occlusion Cure Rate	14 days	The percentage of subjects whose chest drainage tube completely stops leaking air within 14 days after the first endobronchial silicon spigots treatment out of the total number of subjects receiving endobronchial silicon spigots treatment; if a second occlusion is received within 14 days after surgery, it is not counted as a first occlusion cure.
Technical Success Rate	30 days	The proportion of successful placements of the endobronchial silicon spigots into the responsible drainage bronchus out of the total number of operations.

Trial Locations

Locations (1)

The Second Affiliated Hospital of Fujian Medical University; 🇨🇳 Quanzhou, Fujian, China