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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Pneumothorax
• Intervention / Treatment: Device: Endobronchial Silicon Spigots

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liheng Xie; Phone Number: +86-13916444591; Email: medicalaffairs@broncuschina.com

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China, 362018
      • Recruiting
      • The Second Affiliated Hospital of Fujian Medical University
      • Contact: Yiming Zeng, M.D; Phone Number: +86 13515042402; Email: zeng_yi_ming@126.com
      • Principal Investigator: Yiming Zeng, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental Group; All subjects will be assigned to the treatment group to receive the endobronchial silicon spigot treatment.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Occlusion Success Rate	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.	14 days
First Occlusion Cure Rate	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.	14 days
Total Occlusion Cure Rate	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.	42 days
Endobronchial spigots Removal Time	The time (in days) from successful placement of the endobronchial silicon spigots to successful removal of the endobronchial silicon spigots.	30 days
Technical Success Rate	The proportion of successful placements of the endobronchial silicon spigots into the responsible drainage bronchus out of the total number of operations.	30 days
Chest Drainage Tube Removal Rate	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.	28 days
Incidence of Treatment-Emergent Adverse Events	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.	30 days

Collaborators and Investigators

• Sponsor: Hangzhou Broncus Medical Co., Ltd.
• Investigators: Principal Investigator: Yiming Zeng, M.D, The Second Affiliated Hospital of Fujian Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Pneumothorax; spigots; air leakage; bronchial occlusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pneumothorax; Physiological Effects of Drugs; Trace Elements; Micronutrients; Silicon
• Other Study ID Numbers: BC-I-ESS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No