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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
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema Device: lung volume reduction using the Zephyr device

Detailed Description:

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. •Mean % change in lung function (FEV1) [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Mean change in six minutes walk distance [ Time Frame: 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation

  • Age from 40 to 75 years
  • BMI < 32 kg/m2
  • FEV1 < 40% of predicted value, FEV1/FVC < 70%
  • TLC > 120% predicted, RV > 150% predicted.
  • Stable with < 20 mg prednisone (or equivalent) qd
  • PaCO2 < 50mm Hg
  • PaO2 > 45 mm Hg on room air
  • 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation)
  • Nonsmoking for 4 months prior to initial interview and throughout screening
  • The patient agrees to all protocol required follow-up intervals.
  • The patient has no child bearing potential
  • The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria
  • Prior endobronchial treatment for emphysema
  • Pleural or interstitial disease that precludes surgery.
  • Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
  • Clinically significant bronchiectasis
  • Pulmonary nodule requiring surgery
  • History of recurrent respiratory infections (> 3 hospitalization in the last year)
  • Clinically significant (> 4 Tablespoons per day) sputum production
  • Fever, elevated white cell count, or other evidence of active infection
  • Dysrhythmia that might pose a risk during exercise or training
  • Congestive heart failure within 6 mo and LVEF < 45%
  • Evidence or history of Cor Pulmonale
  • Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
  • History of exercise-related syncope
  • MI within 6 mo and LVEF < 45%
  • Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period
  • Any disease or condition that interferes with completion of initial or follow-up assessments
  • Patient is currently enrolled in another clinical trial
  • Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer
  • Alpha-1-Antitrypsin Deficiency

Information from the National Library of Medicine

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


Contacts
Contact: Mordechai Kramer Kramer, MD 97239377140 Kremerm@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 92100
Contact: Mordechai R Kramer, MD    97239377140    kremerm@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01682018     History of Changes
Other Study ID Numbers: RMC126908
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: July 2012

Keywords provided by Rabin Medical Center:
emphysema
lung transplantation

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases