The purpose of this study is to demonstrate the safe use of the PRIMUS System in subjects with chronic cluster headache. This is a single-centre, open label, prospective, first in human study to collect initial clinical data on the PRIMUS system for the treatment of chronic cluster headache.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
PRIMUS system
Resolve Pain
Buderim, Queensland, Australia
Safety Evaluation
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at 30 days.
Time frame: 4 weeks
Safety Evaluation
The primary safety assessment is the incidence of serious procedure and/or device-related adverse events in all subjects at the end of the study.
Time frame: 12 months
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