Actively Recruiting
Safety of Splenic Stimulation for RA
Led by Galvani Bioelectronics · Updated on 2024-02-14
5
Participants Needed
2
Research Sites
388 weeks
Total Duration
On this page
Sponsors
G
Galvani Bioelectronics
Lead Sponsor
N
NAMSA
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety of Splenic Stimulation for RA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult-onset rheumatoid arthritis lasting at least six months
- Male or female participants aged 22 to 75 years
- Active rheumatoid arthritis
- Inadequate response to at least two biologic DMARDs and/or JAK inhibitors
- Appropriate washout period from previously used biological DMARDs or JAK inhibitors
- Female participants must have no child-bearing potential
You will not qualify if you...
- Unable to provide informed consent
- Significant psychiatric illness or substance abuse
- History of unilateral or bilateral vagotomy
- Active or latent tuberculosis
- Known HIV infection or current/previous hepatitis B or C
- Currently have implanted electrically active medical devices (e.g., pacemakers)
- Previous removal of the spleen (splenectomy)
- Use of investigational drugs within 2 weeks or 2 half-lives before surgery
- Uncontrolled inflammatory diseases other than rheumatoid arthritis
- Current or recurrent infections posing risk as judged by the investigator
- History of cancer within the past 5 years except non-malignant skin cancer
- Chronic use of morphine or oxycodone
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology
Amsterdam, Netherlands
Actively Recruiting
2
Greater Glasgow Health Board
Glasgow, United Kingdom, G12 OXH
Actively Recruiting
Research Team
O
Operations Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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