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Chartis System · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Chartis System | DEVICE | Assessment of airway flow and pressure |
Inclusion Criteria: * Scheduled to undergo clinically indicated routine diagnostic bronchoscopy Exclusion Criteria: * Hyperexcretive chronic bronchitis or excessive sputum secretion * Active pulmonary infection * FEV1 \<20% predicted * FVC \<50% predicted
The Chartis System is used for bronchoscopy and for assessing patients with heterogeneous emphysema prior to endobronchial lung volume reduction. It is an investigational device developed by Pulmonx Corporation. Two Phase 1 safety and feasibility studies have been completed to evaluate its use in these settings.
Pulmonx Corporation, traded on NASDAQ under the ticker LUNG, develops the Chartis System. The company is conducting clinical research on this device for bronchoscopy and heterogeneous emphysema applications. The Chartis System is still in clinical development and is not yet approved.
The Chartis System is in Phase 1 clinical development. Two Phase 1 safety and feasibility studies have been completed, one for bronchoscopy and one for heterogeneous emphysema prior to endobronchial lung volume reduction. The device remains investigational and has not received FDA approval.
The Chartis System has completed two Phase 1 trials. NCT00684684 studied safety and feasibility in bronchoscopy with 18 participants in Germany. NCT00684892 studied safety and feasibility in heterogeneous emphysema prior to endobronchial lung volume reduction with 25 participants in Germany. Both trials are completed.
The Chartis System is not FDA approved. It is an investigational device currently in Phase 1 clinical development. Two Phase 1 safety and feasibility studies have been completed, but the device has not yet received regulatory approval for commercial use.