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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 an investigational medical device studied for use in bronchoscopy and in patients with heterogeneous emphysema prior to endobronchial lung volume reduction (ELVR). It is developed by Pulmonx Corporation and is currently in Phase 1 clinical development.
The Chartis System is developed by Pulmonx Corporation, a company traded on the stock exchange under the ticker LUNG. Pulmonx is conducting clinical studies to evaluate the safety and feasibility of the device.
The Chartis System is in Phase 1 clinical development. Two Phase 1 studies have been completed, both focusing on safety and feasibility. The device is investigational and has not been approved by regulatory authorities.
The Chartis System has been studied in two completed Phase 1 trials: NCT00684684, a safety and feasibility study in bronchoscopy with 18 participants, and NCT00684892, a safety and feasibility study in heterogeneous emphysema prior to ELVR with 25 participants. Both trials were conducted in Germany.