Endobronchial Silicone Valve for Patients With Emphysema

China-Japan Friendship Hospital

Status: Not yet enrolling

Conditions: Emphysema

Treatments: Device: EBV; Device: ESV

Study type: Interventional

Funder types: Other

Identifiers

NCT07097896

2025-ESV-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 2 patient groups

ESV and Optimal Medical Management

Experimental group

Description:

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.

Treatment:

Device: ESV

EBV and Optimal Medical Management

Other group

Description:

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.

Treatment:

Device: EBV