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Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.
Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLVR Treatment | Experimental | BLVR Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLVR Treatment | Biological | BLVR Treatment, 10 mL Hydrogel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in gas trapping | 12 weeks post treatment | |
| SAEs - Safety of treatment and the procedure | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in vital capacity | 12 weeks post treatment | |
| Improvement in expiratory flow | 12 weeks post treatment | |
| Improvement in inspiratory flow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor Pinto-Plata, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. | Principal Investigator |
| Gerard Criner, MD | Temple University Lung Center | Principal Investigator |
| Mark Gotfried, MD | Pulmonary Associates | Principal Investigator |
| Charlie Strange, MD | Medical Univ South Carolina Hospital | Principal Investigator |
| Mark Dransfield, MD | Univ of Alabama Birmingham Lung Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham Lung Health Center | Birmingham | Alabama | 35249 | United States | ||
| Pulmonary Associates |
| 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. | |
| 17426216 | Background | Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. doi: 10.1378/chest.06-1754. |
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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 |
| Improvement in dyspnea symptoms (breathlessness) | 12 weeks post treatment |
| Improvement in exercise capacity | 12 weeks post treatment |
| Improvement in respiratory quality of life | 12 weeks post treatment |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Caritas St Elizabeth's Med Cen | Boston | Massachusetts | 02135 | United States |
| Temple University Lung Center | Philadelphia | Pennsylvania | 01940 | United States |
| Medical University of South Carolina Hospital | Charleston | South Carolina | 29425 | United States |
| 19179484 | Derived | Criner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |