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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| permanent Coil(s) implant, QOL measure | Experimental | Coil implantation as treatment. Treatment is permanent implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Volume Reduction Coil (LVRC) | Device | Implantation of Lung Volume Reduction Coil(s) (LVRC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment. | Symptomatic improvement of Quality of Life as measured using the St. George's Respiratory Questionnaire (SGRQ) | Three + Months Follow-Up Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dirk-Jan Slebos, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Prof. Felix JF Herth, MD, PhD | Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Donaustauf | Donaustauf | Germany | ||||
| Asklepios |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25418910 | Derived | Hartman JE, Klooster K, Gortzak K, ten Hacken NH, Slebos DJ. Long-term follow-up after bronchoscopic lung volume reduction treatment with coils in patients with severe emphysema. Respirology. 2015 Feb;20(2):319-26. doi: 10.1111/resp.12435. Epub 2014 Nov 23. | |
| 22116796 | Derived | Slebos DJ, Klooster K, Ernst A, Herth FJF, Kerstjens HAM. Bronchoscopic lung volume reduction coil treatment of patients with severe heterogeneous emphysema. Chest. 2012 Sep;142(3):574-582. doi: 10.1378/chest.11-0730. |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011013 | Pneumonectomy |
| D038481 | Anterior Temporal Lobectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D019635 | Neurosurgical Procedures |
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| Coils | Device | Lung Volume Reduction Coil(s) |
|
|
| Gauting |
| Germany |
| Pneumology and Respiratory Care Medicine Thoraxklinik, University of Heidelberg | Heidelberg | Germany |
| Lungenklinik | Hemer | Germany |
| University Medical Center Groningen | Groningen | 3150-3610536 | Netherlands |