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Safety of Splenic Stimulation for RA
Sponsor: Galvani Bioelectronics
Summary
This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.
Official title: A Single Arm Pilot Study to Evaluate the Safety and Feasibility of Splenic Nerve Stimulation in Patients With Rheumatoid Arthritis Using an Active Implantable Device
Key Details
Gender
All
Age Range
22 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2021-10-20
Completion Date
2029-04
Last Updated
2024-02-14
Healthy Volunteers
No
Conditions
Interventions
Active Stimulation
The Galvani System will be implanted in eligible participants, and stimulation will be turned ON
Locations (2)
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam, Netherlands
Greater Glasgow Health Board
Glasgow, United Kingdom