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The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRIMUS | Experimental | PRIMUS system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRIMUS | Device | PRIMUS system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020. | 30 days |
| Safety Evaluation | The primary safety assessment is the incidence of serious procedure- and/or device-related adverse events in all subjects at 30 days and at the end of the study. All adverse clinical events will be collected, coded, and reported, for the duration of the study according to the definitions of ISO 14155:2020. | 12 months |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Delta | Roeselare | Belgium |
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