NCT04955899Recruiting
Safety of Splenic Stimulation for RA
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
Source: ClinicalTrials.gov · Last updated 14 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 5 Jul 2021
- Start date
- 20 Oct 2021
- Primary completion date
- Apr 2029
- Lead sponsor
- Galvani Bioelectronics
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT04955899
What you commit to
- Study type: Interventional
- Planned participants: 5
- From 20 Oct 2021 to the primary completion date, Apr 2029
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B.
- Previous splenectomy
- Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
Other illness
- Significant psychiatric disease or substance abuse.
- History of unilateral or bilateral vagotomy.
- Active or latent tuberculosis
- Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
- Uncontrolled other inflammatory diseases
- Current/recurrent infections that in the opinion of the PI risk\>benefit.
- History of cancer within the past 5 years, except non-malignant skin cancer.
Other
- Inability to provide informed consent.
- Chronic use of morphine or oxicodone
Who the study is looking for
- Adult-onset RA of at least six months duration
- Male or female participants, 22-75 years of age
- Active RA
- Inadequate Response to at least 2 biologic DMARDs and/or JAK- inhibitors (JAKis)
- Have an appropriate washout from previously used biological DMARDs or JAKi
- A female participant should have no child-bearing potential
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Greater Glasgow Health Board Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.