ConsideRAte Study - Splenic Stimulation for RA
NCT05003310
This study is recruiting at 10 US sites in 6 states, according to its ClinicalTrials.gov record last updated .
Summary
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Rheumatoid Arthritis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Galvani Bioelectronics
- Last updated on ClinicalTrials.gov
- May 22, 2024
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- Medvin Research - Covina · Covina, CA
- Medvin Research - Whittier · Whittier, CA
Maryland · 1
- The Osteoporosis & Clinical Trials Center · Hagerstown, MD
New York · 1
- NYU Langone · Brooklyn, NY
Oregon · 1
- Oregon Health & Science University · Portland, OR
Pennsylvania · 1
- Altoona Center for Clinical Research · Altoona, PA
Texas · 4
- Arthritis & Rheumatology Institute · Allen, TX
- St. David's Healthcare · Austin, TX
- Tekton Research · Austin, TX
- Southwest Rheumatology Research · Mesquite, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.