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| ID | Type | Description | Link |
|---|---|---|---|
| IRB Protocol # 2003-P-002171 |
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The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.
Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single | Experimental | Treatment with BLVR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLVR | Biological | 10 mL Hydrogel |
|
| Measure | Description | Time Frame |
|---|---|---|
| SAEs - Safety | 1 year post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PFTs | 12 weeks post treatment | |
| Dyspnea | 12 weeks post treatment | |
| Exercise capacity |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John J. Reilly, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Caritas St Elizabeth's Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12406835 | Background | Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11. |
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| ID | Term |
|---|---|
| D011656 | Pulmonary Emphysema |
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 12 weeks post treatment |
| QOL | 12 weeks post treatment |
| Boston |
| Massachusetts |
| 02135 |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |