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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
The Salvia PRIMUS System is designed to provide subcutaneous neurostimulation to the branches of the trigeminal and occipital nerves.
Genesis Research Services
Broadmeadow, New South Wales, Australia
ACTIVE_NOT_RECRUITINGResolve Pain
Buderim, Queensland, Australia
ACTIVE_NOT_RECRUITINGZAS Antwerpen, Campus Sint-Augustinus
Safety Evaluation
The incidence of serious procedure, device and/or stimulation-related adverse events.
Time frame: 12 weeks
Effectiveness Evaluation
Proportion of subjects with ≥ 30% reduction in the number of Monthly Migraine Days (MMD), in randomized arms.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wilrijk, Antwerpen, Belgium
Jessa Hasselt
Hasselt, Limburg, Belgium
RECRUITINGPrivate Practice Dr. Sava
Saint-Nicolas, Liège, Belgium
ACTIVE_NOT_RECRUITINGAZ Sint Jan Brugge
Bruges, West Vlaanderen, Belgium
RECRUITINGAZ Groeninge
Kortrijk, West Vlaanderen, Belgium
RECRUITINGAZ Oostende
Ostend, West Vlaanderen, Belgium
RECRUITINGAZ Delta
Roeselare, West Vlaanderen, Belgium
RECRUITINGSt. Antonius Nieuwegein
Nieuwegein, Netherlands
RECRUITING...and 1 more locations