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Lung Volume Reduction Coil · 2 trials · 1 indication
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...
The Lung Volume Reduction Coil is used for emphysema, a form of chronic obstructive pulmonary disease. It is an investigational device being studied to reduce lung volume in patients with this condition. The device is in clinical development and has not been approved by the FDA.
Boston Scientific Corporation (BSX) is developing the Lung Volume Reduction Coil. The company is conducting clinical trials to evaluate the device for the treatment of emphysema. Boston Scientific is the developer of this investigational device.
The Lung Volume Reduction Coil is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 feasibility study and a Phase 2 mechanism of action study. The device remains investigational and is not yet approved for commercial use.
The Lung Volume Reduction Coil has completed two clinical trials: NCT01328899, a Phase 1 feasibility study with 60 participants in France, Germany, and the Netherlands, and NCT01421082, a Phase 2 study with 10 participants in the Netherlands. Both trials were for emphysema and are now completed.
The Lung Volume Reduction Coil is designed to reduce lung volume in patients with emphysema. The mechanism of action was evaluated in a Phase 2 study (NCT01421082) that assessed physiologic parameters to understand how the device works in subjects with homogeneous emphysema.