Condition: Rheumatoid Arthritis · Sponsor: Galvani Bioelectronics
This study will evaluate the safety, tolerability, and effects of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. The study will consist of 4 study periods, including a Randomized Control Trial period (Period 1), an Open Label period (Period 2), a Treat-to-target period (Period 3), and a Long-term Follow-up period (Period 4). 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). A sufficient number of participants will be enrolled so that approximately 28 participants will undergo device implantation.
This description comes directly from the study's public registry record.
Operations Director · +1 877 613 9001 · clinical@galvani.bio
Always discuss trial participation with your own doctor first.
| Pinnacle Research Group, LLC | Anniston, Alabama, United States | Withdrawn |
| Medvin Research - Covina | Covina, California, United States | Recruiting |
| Medvin Research - Whittier | Whittier, California, United States | Recruiting |
| The Osteoporosis & Clinical Trials Center | Hagerstown, Maryland, United States | Recruiting |
| NYU Langone | Brooklyn, New York, United States | Recruiting |
| Oregon Health & Science University | Portland, Oregon, United States | Recruiting |
| Altoona Center for Clinical Research | Altoona, Pennsylvania, United States | Recruiting |
| Arthritis & Rheumatology Institute | Allen, Texas, United States | Recruiting |
| St. David's Healthcare | Austin, Texas, United States | Recruiting |
| Tekton Research | Austin, Texas, United States | Recruiting |
| Metroplex Clinical Research Center | Dallas, Texas, United States | Withdrawn |
| Southwest Rheumatology Research | Mesquite, Texas, United States | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05003310