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

NCT06515015 | Recruiting

• 1 other identifier: BC-I-ESS-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Pneumothorax; spigots; air leakage; bronchial occlusion

Outcome Measures

Primary Outcomes (1)

• Total Occlusion Success Rate

  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.

  7 days

Secondary Outcomes (7)

• First Occlusion Success Rate

  14 days

• First Occlusion Cure Rate

  14 days

• Total Occlusion Cure Rate

  42 days

• Chest Drainage Tube Removal Rate

  28 days

• Endobronchial spigots Removal Time

  30 days

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Device: Endobronchial Silicon Spigots

Interventions

Endobronchial Silicon Spigots 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.

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Broncus Medical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362018, China

RECRUITING

MeSH Terms

Conditions

Pneumothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Yiming Zeng, M.D

  The Second Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liheng Xie

CONTACT

+86-13916444591; medicalaffairs@broncuschina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CN (1)