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The purpose of this study is to evaluate the safety and performance, including clinical benefit, of the PRIMUS System for the treatment of Resistant Migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Treatment Group | Experimental | Active therapy modality |
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| Cohort 1 - Control Group | Other | Sham therapy |
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| Cohort 2 - Therapy V | Experimental | Active therapy modality |
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| Cohort 2 - Therapy D | Experimental | Active therapy modality |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRIMUS | Device | The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation | The incidence of serious procedure, device and/or stimulation-related adverse events. | 12 weeks |
| Effectiveness Evaluation | Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Research Services | Active, not recruiting | Broadmeadow | New South Wales | NSW, 2292 | Australia | |
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| Resolve Pain |
| Active, not recruiting |
| Buderim |
| Queensland |
| 4556 |
| Australia |
| ZAS Antwerpen, Campus Sint-Augustinus | Recruiting | Wilrijk | Antwerpen | Belgium |
|
| Jessa Hasselt | Recruiting | Hasselt | Limburg | 3500 | Belgium |
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| Private Practice Dr. Sava | Active, not recruiting | Saint-Nicolas | Liège | Belgium |
| AZ Sint Jan Brugge | Recruiting | Bruges | West Vlaanderen | 8000 | Belgium |
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| AZ Groeninge | Recruiting | Kortrijk | West Vlaanderen | Belgium |
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| AZ Oostende | Recruiting | Ostend | West Vlaanderen | Belgium |
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| AZ Delta | Recruiting | Roeselare | West Vlaanderen | Belgium |
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| St. Antonius Nieuwegein | Recruiting | Nieuwegein | Netherlands |
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| Erasmus MC Rotterdam | Recruiting | Rotterdam | Netherlands |
|