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This is a multi-center, open-label, non-controlled Pilot Study. Approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). Patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. All patients will receive treatment in a single lung under conscious sedation or general anesthesia. Patients will be followed for 24 weeks after completion of PLVR treatment(s). Upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. Thereafter, Group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. All study patients will receive standard medical therapy in addition to PLVR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLVR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymeric Lung Volume Reduction System (PLVR) | Device | 20ml (each) of polymer will be injected into 2, 3 or 4 subsegments during the first treatment. Eligible patients may have 20ml (each) of polymer will be injected into 2 or 3 subsegments during the second treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | Change from baseline in RV/TLC ratio at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in 1 Second (FEV1) | o Change from baseline in FEV1 (post bronchodilator) at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment |
| Change in Forced Vital Capacity (FVC) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chefarzt Klinik für Pneumologie | Bad Berka | Germany | ||||
| Charité Universitätsmedizin Medizinische Klinik Infektiologie und Pulmologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33590989 | Derived | Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344. | |
| 22374920 | Derived | Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28. |
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Change from baseline in FVC (post bronchodilator) at 12 and 24 weeks following treatment
| 12 and 24 weeks following treatment |
| Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLco) | Change from baseline in DLco at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment |
| Change in Medical Research Council Dyspnea (MRCD) score | Change from baseline in MRCD score at 12 and 24 weeks | 12 and 24 weeks following treatment |
| Change in distance walked in six minutes | Change from baseline at 12 and 248 weeks in 6 Minutes Walk Test (6MWT) | 12 and 24 weeks following treatment |
| Change in St. George's Respiratory Questionnaire (SGRQ) domain score | Change from baseline in disease-specific health related quality of life assessment (SGRQ) at 12 and 24 weeks following treatment | 12 and 24 weeks following treatment |
| Berlin |
| Germany |
| Pneumologisches Forschungsinstitut | Großhansdorf | Germany |
| Thoraxklinik Heidelberg | Heidelberg | Germany |
| Lungenklinik Hemer | Hemer | Germany |
| Medizinische Klinik und Poliklinik Klinikum Großhadern | Munich | Germany |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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