Endobronchial Silicone Valve for Patients With Emphysema

Official title

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

Overview

The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.

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 optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group. 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 after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.

Interventions

• 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 Optimal Medical Management (OMM)
  This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.

Primary outcome measures

• Forced Expiratory Volume in 1-second (FEV1) [Time frame: 1-year]

Secondary outcome measures (3)

• FEV1 Post-bronchodilator Absolute Change [Time frame: 1 year]
• St. George's Respiratory Questionnaire (SGRQ) [Time frame: 1 year]
• 6-minute Walk Distance [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• China-Japan Friendship Hospital — Beijing

Identifiers

NCT: NCT07097896 · 2025-ESV-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗