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| Name | Class |
|---|---|
| PneumRx, Inc. | INDUSTRY |
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The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Volume Reduction Coil (LVRC) | Experimental | Lung Volume Reduction Coil (LVRC) |
|
| Control | Placebo Comparator | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lung Volume Reduction Coil (LVRC) (PneumRx) | Device | Lung Volume Reduction Coil (LVRC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| St. George's Respiratory Questionnaire (SGRQ) | The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit. | three month Follow-Up Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pallav Shah, MD | Chelsea and Westminster Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glasgow | United Kingdom | |||||
| Chelsea and Westminster Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25853697 | Derived | Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL. Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015. | |
| 24429129 |
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| Control | Device | Standard of Care |
|
|
| London |
| United Kingdom |
| Manchester | United Kingdom |
| Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23. |
| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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