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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

Primary Purpose

Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
lung volume reduction using the Zephyr device
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema focused on measuring emphysema, lung transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

•Mean % change in lung function (FEV1)

Secondary Outcome Measures

Mean change in six minutes walk distance

Full Information

First Posted
September 5, 2012
Last Updated
September 7, 2012
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01682018
Brief Title
The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema
Keywords
emphysema, lung transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
lung volume reduction using the Zephyr device
Intervention Description
lung volume reduction using the Zephyr device
Primary Outcome Measure Information:
Title
•Mean % change in lung function (FEV1)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Mean change in six minutes walk distance
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mordechai Kramer Kramer, MD
Phone
97239377140
Email
Kremerm@clalit.org.il
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
92100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mordechai R Kramer, MD
Phone
97239377140
Email
kremerm@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

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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