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| Name | Class |
|---|---|
| Beijing Cardiotech Medical Technology CO., LTD | UNKNOWN |
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The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESV and Optimal Medical Management | Experimental | 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. |
|
| Optimal Medical Management | Other | This study arm will undergo optimal medical management, including smoking cessation program, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESV | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingming Deng, PhD., MD. | Contact | +86 18801336854 | isdeng1017@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Optimal Medical Management (OMM) | Other | This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary. |
|
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 |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |