NCT04955899

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
36mo left

Started Oct 2021

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Oct 2021Apr 2029

First Submitted

Initial submission to the registry

July 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2021

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

7.5 years

First QC Date

July 5, 2021

Last Update Submit

February 12, 2024

Conditions

Rheumatoid Arthritis

Keywords

Electrical stimulationinflammationactive implantable medical deviceLaparoscopyantirheumatic agentsautonomic nervous systemfeasibility studies

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of the Galvani system

    Incidence and relatedness of Adverse Events (AEs), which include clinically significant findings from Laboratory Safety Assessments (clinical chemistry and hematology), vital signs (blood pressure, heart rate, respiratory rate, and body temperature), and 12-Lead ECG

    12 weeks

Secondary Outcomes (4)

  • Effect of stimulation on the change in pharmacodynamic and response biomarkers

    Day 1 to week 12

  • To evaluate the usability of the external Galvani System devices and accessories

    12 weeks

  • To evaluate the participants' perception of therapy and sensation

    12 weeks

  • Evaluate device performance

    12 weeks

Study Arms (1)

Active Stimulation

EXPERIMENTAL

Active stimulation for 12 weeks

Device: Active Stimulation

Interventions

Active StimulationDEVICE

The Galvani System will be implanted in eligible participants, and stimulation will be turned ON

Active Stimulation

Eligibility Criteria

Age22 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to provide informed consent.
  • Significant psychiatric disease or substance abuse.
  • History of unilateral or bilateral vagotomy.
  • Active or latent tuberculosis
  • Known infection with human immunodeficiency virus (HIV); current acute or chronic hepatitis B or hepatitis C; previous hepatitis B.
  • Currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators).
  • Previous splenectomy
  • Any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery.
  • 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.
  • Chronic use of morphine or oxicodone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Academic Medical Center (AMC) Dept of Rheumatology & Clinical Immunology

Amsterdam, Netherlands

RECRUITING

Greater Glasgow Health Board

Glasgow, G12 OXH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidInflammation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Operations Director

CONTACT

+44 (0)800 3688514clinical@galvani.bio

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

July 9, 2021

Study Start

October 20, 2021

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

NL(1)GB(1)