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This registry will provide insights into the use of Okami Medical devices in real-world clinical and study effectiveness and safety of Okami Medical devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analysis Population 1 | Patients treated for the control of peripheral arterial bleeding/hemorrhage. |
| |
| Analysis Population 2 | Patients treated for pulmonary arteriovenous malformations. |
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| Analysis Population 3 | Patients treated with the LOBO Vascular Occlusion System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LOBO Vascular Occlusion System | Device | LOBO Vascular Occlusion System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint | Incidence of device-related serious adverse events during the index procedure | 30 days post-index procedure |
| Effectiveness Endpoint | Technical success of the LOBO Vascular Occlusion System defined as occlusion of the intended target(s) with the LOBO occluder, assessed by angiography | During index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a clinical condition treated with LOBO Vascular Occlusion System
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| UMASS Chan Medical School |
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| ID | Term |
|---|---|
| C562404 | Pulmonary Arteriovenous Fistulas |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Worcester |
| Massachusetts |
| 01655 |
| United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |