Emphysema Clinical Trial
Official title:
A Prospective Feasibility Study to Evaluate the Safety and Performance of the Exhale(R) Drug-Eluting Stent System in Patients With Emphysema
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2006 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. High resolution computed tomography (CT) scan evidence of bilateral emphysema 2. Residual volume (RV) = 220% predicted. 3. Total lung capacity (TLC) = 133% of predicted value. 4. Forced expiratory volume (FEV1) < 40% of predicted or FEV1 < 1 liter. 5. Marked dyspnea, scoring = 2 on the modified Medical Research Council scale of 0-4. 6. Patient has undergone pulmonary rehabilitation of 16 - 20 sessions. Exclusion Criteria: 1. FEV1 > 20% 2. Diffusing capacity for carbon monoxide (DLco) < 15% of predicted. 3. Respiratory infection requiring > 3 hospitalizations in past year 4. Inability to walk > 140 meters in 6 minutes 5. Giant bulla > 1/3 of one lung's volume 6. Previous lung volume reduction surgery (LVRS) or lobectomy. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Concord Repatriation General Hospital | Burwood | |
Australia | The Alfred Hospital | Prahran | Victoria |
Australia | The Prince Charles Hospital | Rode Road, Chermside | Queensland |
Brazil | Irmandade Santa Casa de Misericordia | Porto Alegre | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Universitätsklinik des Saarlandes | Homburg | Saarland |
Lead Sponsor | Collaborator |
---|---|
Broncus Technologies |
Australia, Brazil, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedural and technical success - operatively | |||
Primary | Decrease in residual volume > 300mL from baseline | |||
Primary | Safety | |||
Secondary | Dyspnea scoring | |||
Secondary | Pulmonary function measures | |||
Secondary | Exercise tolerance | |||
Secondary | Quality of life measures |
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