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

NCT ID: NCT06515015

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-08-31

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.

Conditions

Pneumothorax

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

All subjects will be assigned to the treatment group to receive the endobronchial silicon spigot treatment.

Group Type: EXPERIMENTAL

Endobronchial Silicon Spigots

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Broncus Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yiming Zeng, M.D

Role: PRINCIPAL_INVESTIGATOR

The Second Affiliated Hospital of Fujian Medical University

Locations

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liheng Xie

Role: CONTACT

medicalaffairs@broncuschina.com

+86-13916444591

Facility Contacts

Yiming Zeng, M.D

Role: primary

zeng_yi_ming@126.com

+86 13515042402

Other Identifiers

BC-I-ESS-01

Identifier Type: -

Identifier Source: org_study_id