Endobronchial Silicone Valve for Patients With Emphysema

Bronchoscopic Lung Volume Reduction With Endobronchial Silicone Valve for Patients With Emphysema: a Randomised Controlled Trial

The purpose of this research is to compare the efficacy and safety between endobronchial silicone valve and endobronchial valve in bronchoscopic lung volume reduction in patients with severe emphysema.

Study Overview

• Status: Not yet recruiting
• Conditions: Emphysema
• Intervention / Treatment: Device: EBV; Device: ESV

Detailed Description

The Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) is a novel designed implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The ESV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.

This clinical trial included two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) with optimal medical therapy. The 'Control' group will receive Zephyr Endobronchial Valve (EBV) in combination with optimal medical therapy. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group.

It is hypothesized that the ESV has similar efficacy and safety to EBV in treating patients with severe emphysema.

• Study Type: Interventional
• Enrollment (Estimated): 147
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingming Deng, PhD., MD.; Phone Number: +86 18801336854; Email: isdeng1017@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Clinical and radiological evidence of emphysema
• Nonsmoking for 4 months prior to screening interview
• BMI less than 35 kg/m2
• Stable on current medication regimen
• Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value
• Residual Volume less than 175% predicted (determined by body plethysmography)
• Little or no collateral ventilation (CV-) as determined using the Chartis System

Exclusion Criteria:

• Had two or more hospitalizations over the last year for a COPD exacerbation
• Had two or more hospitalizations over the last year for pneumonia
• Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy
• Had a heart attack or congestive heart failure within the last 6 months
• Have heart arrhythmia
• Is alpha-1 antitrypsin deficient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESV and Optimal Medical Management; This study arm will undergo ESV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.	Device: ESV; This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Other: EBV and Optimal Medical Management; This study arm will undergo EBV treatment along with optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.	Device: EBV; This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume in 1-second (FEV1)	Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).	1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 Post-bronchodilator Absolute Change	Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline).	1 year
St. George's Respiratory Questionnaire (SGRQ)	Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency & severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations.	1 year
6-minute Walk Distance	Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline).	1 year

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Beijing Cardiotech Medical Technology CO., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 30, 2025
• First Submitted That Met QC Criteria: July 30, 2025
• First Posted (Actual): August 1, 2025

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Emphysema; Endobronchial Lung Volume Reduction
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 2025-ESV-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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