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RECRUITING
NCT04955899
NA

Safety of Splenic Stimulation for RA

Sponsor: Galvani Bioelectronics

View on ClinicalTrials.gov

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

Interventions

DEVICE

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