Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01421082 | Evaluation of Physiologic Parameters to Study the Mechanism of Action of the Lung Volume Reduction Coil in Subjects With Homogeneous Emphysema | PHASE2 | COMPLETED | 10 | — | — | Feb 1, 2012 | Mar 1, 2013 | Jul 16, 2021 | 1 | Netherlands |
| NCT01328899 | Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC) | PHASE1 | COMPLETED | 60 | — | — | Dec 1, 2009 | Jan 1, 2013 | Jul 21, 2021 | 11 | France, Germany +1 |
The primary effectiveness endpoint will be the improvement in the 6 minute walk test (6MWT) from Baseline compared to Follow-Up.
Symptomatic improvement in St. George's Respiratory Questionnaire (SGRQ) from Baseline
| Arm | Type | Description |
|---|---|---|
| LVRC Treatment | EXPERIMENTAL | - |
| Lung Volume Reduction Coil (LVRC) | EXPERIMENTAL | Lung Volume Reduction Coil (LVRC) |
| Name | Type | Description |
|---|---|---|
| Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.) | DEVICE | Lung Volume Reduction Coil (LVRC) |
| Lung Volume Reduction Coil (LVRC) (PneumRx's) | DEVICE | Lung Volume Reduction Coil |
Inclusion Criteria: Subject \> 35 years of age CT scan indicates homogeneous emphysema Subject has stopped smoking for a minimum of 6 months prior Subject (and legal guardian if applicable) read, understood and signed the Informed Consent form Exclusion Criteria: Subject has a history of recurren...