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Exhale (R) Stent for Emphysema

Primary Purpose

Emphysema

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Exhale Drug-Eluting Stent
Sponsored by
Broncus Technologies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring COPD (Chronic Obstructive Pulmonary Disease), Emphysema, Minimally invasive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: High resolution computed tomography (CT) scan evidence of bilateral emphysema Residual volume (RV) ≥ 220% predicted. Total lung capacity (TLC) ≥ 133% of predicted value. Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 liter. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4. Patient has undergone pulmonary rehabilitation of 16 - 20 sessions. Exclusion Criteria: FEV1 > 20% Diffusing capacity for carbon monoxide (DLco) < 15% of predicted. Respiratory infection requiring > 3 hospitalizations in past year Inability to walk > 140 meters in 6 minutes Giant bulla > 1/3 of one lung's volume Previous lung volume reduction surgery (LVRS) or lobectomy.

Sites / Locations

  • The Prince Charles Hospital
  • The Alfred Hospital
  • Concord Repatriation General Hospital
  • Irmandade Santa Casa de Misericordia
  • Universitätsklinik des Saarlandes
  • Medizinische Hochschule Hannover

Outcomes

Primary Outcome Measures

Procedural and technical success - operatively
Decrease in residual volume > 300mL from baseline
Safety

Secondary Outcome Measures

Dyspnea scoring
Pulmonary function measures
Exercise tolerance
Quality of life measures

Full Information

First Posted
September 12, 2005
Last Updated
January 21, 2008
Sponsor
Broncus Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT00207337
Brief Title
Exhale (R) Stent for Emphysema
Official Title
A Prospective Feasibility Study to Evaluate the Safety and Performance of the Exhale(R) Drug-Eluting Stent System in Patients With Emphysema
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Broncus Technologies

4. Oversight

5. Study Description

Brief Summary
Current treatment for emphysema is limited to measures that include inhaled oxygen, bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive procedures such as lung volume reduction surgery or lung transplantation are also performed. Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic treatment that has the potential to reduce shortness of breath in emphysema patients. This study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.
Detailed Description
Emphysema affects an estimated 60 million people worldwide and is a major cause of morbidity and mortality. In its most basic terms, emphysema causes the destruction of lung parenchyma resulting in collateral ventilation from one part of the lung to another through the disrupted alveolar walls, to the point that gas transport from one part of the lung to another may exceed gas flow through the small airways. In other words, the gas can move freely about within the lung, but it cannot get out, which causes over inflation, or hyperinflation of the diseased lung. When the disease is far advanced, patients are afflicted with disabling dyspnea that progressively restricts their activities and eventually causes great suffering. The crippling effects of end-stage emphysema, including severe dyspnea and marked limitation of activities, relate in large measure to the dynamic hyperinflation of the lungs associated with the loss of elasticity, gas trapping and collapse of small airways. The progressive enlargement of the thorax and flattening of the diaphragm render inspiratory muscles inefficient, increase the work of breathing and contribute to a feeling of breathlessness. The major medical therapeutic modalities include bronchodilator and anti-inflammatory drugs directed at decreasing airway resistance and antibiotics to combat infection. Pulmonary rehabilitation techniques and exercise training have proven of palliative benefit. In general, the results of medical treatment for advanced airway obstruction frequently result in a persistently anguished patient and frustrated physician. A system that could efficiently decompress emphysematous lungs with each breath would result in significant clinical benefit, including lessened dyspnea, decreased work of breathing, and increased exercise tolerance. In addition to medical therapies, there are two surgical therapies available to emphysema sufferers: Lung transplantation and Lung Volume Reduction Surgery (LVRS). In the National Emphysema Treatment Trial (NETT), LVRS was shown to be effective in a sub-set of emphysema patients, but it had the drawback of increased short-term mortality as compared to the medical control arm. This was likely due to the invasiveness of LVRS. Lung transplantation is a widely accepted surgical treatment for emphysema; however it is an unrealistic option for most patients. The selection criteria are very stringent for acceptance to receive a donor lung(s). Lung transplantation carries a high long-term morbidity and mortality and is severely limited by the shortage of available donor lungs. We seek to take advantage of collateral ventilation seen in advanced emphysema by creating passageways from the lung parenchyma to large airways, through which air can escape the lungs during exhalation. The Exhale therapeutic intervention should be applicable to the majority of emphysema patients who suffer from hyperinflation of their lungs. It would be desirable to have a therapeutic option that is both less invasive and more readily available to emphysema sufferers. We have been working on such a therapy and have begun to investigate it in the clinic.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema
Keywords
COPD (Chronic Obstructive Pulmonary Disease), Emphysema, Minimally invasive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Exhale Drug-Eluting Stent
Primary Outcome Measure Information:
Title
Procedural and technical success - operatively
Title
Decrease in residual volume > 300mL from baseline
Title
Safety
Secondary Outcome Measure Information:
Title
Dyspnea scoring
Title
Pulmonary function measures
Title
Exercise tolerance
Title
Quality of life measures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High resolution computed tomography (CT) scan evidence of bilateral emphysema Residual volume (RV) ≥ 220% predicted. Total lung capacity (TLC) ≥ 133% of predicted value. Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 liter. Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4. Patient has undergone pulmonary rehabilitation of 16 - 20 sessions. Exclusion Criteria: FEV1 > 20% Diffusing capacity for carbon monoxide (DLco) < 15% of predicted. Respiratory infection requiring > 3 hospitalizations in past year Inability to walk > 140 meters in 6 minutes Giant bulla > 1/3 of one lung's volume Previous lung volume reduction surgery (LVRS) or lobectomy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory I. Snell, MD
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Rode Road, Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
The Alfred Hospital
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Burwood
ZIP/Postal Code
2134
Country
Australia
Facility Name
Irmandade Santa Casa de Misericordia
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Facility Name
Universitätsklinik des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.broncus.com
Description
Broncus Technologies, Inc corporate web page
URL
http://www.lungusa.org
Description
American Lung Association

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Exhale (R) Stent for Emphysema

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