The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
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|ClinicalTrials.gov Identifier: NCT01682018|
Recruitment Status : Unknown
Verified July 2012 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : September 10, 2012
Last Update Posted : September 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema||Device: lung volume reduction using the Zephyr device||Not Applicable|
Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction.
Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR.
The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
Experimental: intervention group
Patients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung
Device: lung volume reduction using the Zephyr device
lung volume reduction using the Zephyr device
- •Mean % change in lung function (FEV1) [ Time Frame: 90 days ]
- Mean change in six minutes walk distance [ Time Frame: 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682018
|Contact: Mordechai Kramer Kramer, MD||97239377140||Kremerm@clalit.org.il|
|Rabin Medical Center||Not yet recruiting|
|Petah Tikva, Israel, 92100|
|Contact: Mordechai R Kramer, MD 97239377140 firstname.lastname@example.org|