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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06249529 | Airway Bypass - Safety and Feasibility Study | EARLY_PHASE1 | RECRUITING | 10 | — | — | Jan 26, 2024 | Jun 1, 2026 | Feb 8, 2024 | 1 | Georgia |
including but not limited to device-related blood vessel perforation, pneumothorax, COPD exacerbation, device migration, device removal, rehospitalization.
| Arm | Type | Description |
|---|---|---|
| Interventional | EXPERIMENTAL | Patients in the interventional arm will receive implant of one or more airway bypass devices. |
| Name | Type | Description |
|---|---|---|
| Airway Bypass | DEVICE | Bypass stent(s) are implanted to allow air trapped in the parenchyma to escape |
Inclusion Criteria: 1. Patient between 50 to 80 years old. 2. High Resolution CT scan indicates severe emphysema. 3. Patient has post- bronchodilator FEV1 less than or equal to 50% of predicted. 4. Total Lung Capacity \>100% of predicted. 5. Residual volume ≥225 % of predicted. 6. RV/TLC \>0.69 7. ...